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Project Engineer

November 9, 2022

Summary

The Project Engineer will be heavily involved in capital project planning, management, and close-out for manufacturing, utility and lab area upgrades and renovations. Demonstrates the ability to successfully plan complex engineering and technology projects and sustain high quality engineering and technology contributions in a GMP environment. Interfaces with all company groups and key business partners (Viral Vector Manufacturing, Cell Therapy Processing, Plasmids Manufacturing, Testing & Analytical Services, Process Development). Proactively looks for and recommends improvements in site processes and procedures.

Responsibilities

Work with a cross-functional team of scientists, automation engineers, facilities staff, and operations experts to rapidly respond to evolving GMP manufacturing and laboratory utilization needs for CDMO client projects

Incumbent coordinates development of project budgets for execution including project construction and procurement estimating. Consults with manager on development of long range capital planning and data acquisition for site master planning and program management.

Perform functions to provide technical guidance for execution of small projects with no supervision. Make decisions independently and inform Project Leader or Sponsor of actions taken.

Assemble and lead small project teams for capital project planning and execution

Engagement with Facilities group to assist with identification, development, planning and delivery of expense projects and management of facilities shutdown activities.

Solicit and manage contractors (mechanical, electrical, automation, validation, etc.) in capital project execution

Qualify vendor, solicit bids, review bid contents, expedite equipment delivery, equipment problems communication and coordinate vendor equipment startup

Support facility design and capital project execution projects with process input.

Develop project management and quality project delivery procedures and adhere to relevant policies for interaction with project design (architecture & engineering firms) and delivery partners (construction managers).

Maintain high degree of familiarity on technology advancements in cell and gene therapy production processes, equipment, instrumentation and systems.

Qualifications

● 5+ years experience in project management for design and improvement of biopharmaceutical/ATMP manufacturing and laboratory facilities.

● Familiar with project identification & development, expedited project delivery approaches,

● Ability to combine technical knowledge and project delivery, providing the best possible project outcomes while retaining focus on cost and schedule constraints.

● Strong organizational, interpersonal, speaking and written communication skills

● Prioritizing multiple commitments and technical problem solving aptitude

● Ability to shift priorities according to changes in department/facility needs and actively consider different ideas/approaches/options.

● Knowledge of MS Project, Visio, Team and Office suite of software is a must.

● Project Management Professional (PMP) or Certified Associate in Project Management (CAPM) certification would be a plus

AutoCAD design and Bluebeam Revu PDF editing experience is a plus.

Education & Experience

● B.S. in an Engineering discipline (chemical or mechanical preferred).

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Validation Engineer

October 26, 2022

Summary

The Validation Engineer will be responsible for providing commissioning, qualification, and validation support with regard to site facilities, utilities, equipment, processes, an/or systems. This role will drive and execute tasks throughout all phases of the validation lifecycle in order to maintain compliance and meet project deadlines. He/she will be responsible for their day-to-day activities including execution, protocol management, vendor management issues, deviations, corrections and remediation efforts for facility, utility, equipment, systems, and processes in support of personalized cell and gene therapy production and associated development & analytical processes through safe and compliant manufacturing and testing operations according to cGMP requirements. This role requires CQV and engineering experience, ability to work independently, drive effective communication, coordination, and collaboration across relevant cross functional groups in support of the CQV program

Qualifications

Ø Participate in providing a planned, documented and managed approach to the commissioning, qualification testing of cGMP systems and equipment to include associated maintenance activities.

Ø Authors, owns and executes CQV protocols, summary reports and data acquisition in compliance with CBM standard operational procedures and regulatory requirements

Ø Collaborates and coordinates with appropriate departments and/or outside contractors/vendors regarding the scheduling or implementation of validation testing

Ø Responsible for assigned CQV projects including core team representation, prioritization, tracking of commissioning/qualification tasks, and status reports to ensure on-time project delivery

Ø Understands existing system boundaries and assists CQV management with establishing any new system boundaries, scope of work and commissioning execution plans

Ø Supports project specific written commissioning and qualification procedure for new system and continue re-validation efforts on existing systems

Ø Supports the authoring of risk assessments, FMEAs, periodic qualifications, project plans, master plans and annual product reviews as assigned

Ø Supports quality investigations, CAPAs and corrections to supporting documentation as needed

Ø Supports any required remediation efforts and associated CAPA plans as assigned by CQV management.

Ø Participates in the creation, revision, and review of controlled documentation as it pertains to CQV processes and requirements

Performs other related duties as assigned

Education & Experience

Ø Bachelor’s degree in science, engineering or equivalent technical discipline is required

Experience:

Ø Minimum of 5 years’ relevant experience required in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance or manufacturing compliance

Ø Proven work experience in validation required or Current Good Manufacturing Practices (cGMP)

Ø Excellent written and oral communication skills.

Ø Possesses high level of interpersonal skills and work collaboratively in a team environment.

Ø High level of “attention to detail”

Ø Must be highly organized in order to operate in a fast-paced dynamic work environment while adhering to established deadlines of projects

Ø Must have a solid team player attitude and flexibility to accept rapid changing priorities while remaining professional at all times

Ø Proficient in use and application of computer software, such as MS Teams, MS Excel, MS Access, MS Word, and Google applications.

Ø Experience with Quality Management Systems for controlled documentation (Veeva experience is a plus)

Ø Experience utilizing ValGenesis and/or Blue Mountain RAM is a plus

Ø Thorough understanding of industry standards and regulatory guidelines.

Ø Ability to communicate effectively with management, coworkers, clients, client operations, vendors, contractors, and other stakeholders

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Calibration and Maintenance Scheduler

October 13, 2022

Summary

Center for Breakthrough Medicines is seeking an experienced Calibration and Maintenance Scheduler to operate and maintain or repair systems and equipment to ensure uptime and reliability, regulatory compliance and overall department work performance goals. Ensure quality and safety standards are met and the maintenance operations are efficient and reliable. Maintain process systems and equipment in highest level of compliance and cleanliness and ensure operating procedures and maintenance work orders are executed in accordance with all regulations.

Responsibilities

  • Maintain all equipment and systems in a state of readiness matching the needs of the business.
  • Coordinate between Equipment owners and outside vendors to get all necessary calibrations and maintenance performed on schedule.
  • Manage Service Contracts for Lab and Process Equipment.
  • Interact with area customers in a professional manner to apprise them of the situation, ongoing status, and results achieved.
  • Resolve problems while maintaining compliance with cGMP or cGLP requirements.
  • Report problems and findings or work results to department management, as necessary.
  • Assist in the investigation of any deviations or atypical events as needed.
  • Review and close completed work orders in the department CMMS.
  • Develop procedures for work methods to sustain or improve the equipment or processes as requested.
  • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to the plant working groups.
  • Review personal performance regularly and develop self within operating functions to continually enhance individual and overall work team performance.
  • Provide periodic reports on operating metrics and improvement initiatives.
  • Ensure all maintenance is completed properly and on time and that a record of completion is kept.
  • Requisition repair materials and equipment as required for the maintenance of facilities

Qualifications

  • High School diploma, and Recognized Trade/Vocational school or equivalent military/construction trades training or apprenticeship.
  • 7 years of journeyman level experience in a technical trade such as HVAC-R, I/E&C, Building Ops, or Maintenance or Construction Trades.
  • Experience with BM RAM R4 is a plus
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Project Controls Team Leader

August 23, 2022

Summary:

Responsible for Project Controls at the Center for Breakthrough Medicines. Management of resources to ensure effective project controls for all commercial, contractual and schedule aspects of the Project. Requires knowledge base inclusive of cost reporting and forecasting, progress and performance measurement, planning / scheduling and change management.

Responsibilities:

  • Establish plans to develop, monitor, control and maintain project budgets and schedules by utilizing proven cost control, progress measurement and scheduling systems.
  • Monitor, report and control costs and schedules during all phases of the program from Preliminary Engineering through Validation.
  • Change Management – manage and pursue all changes by continuously monitoring scope of work and incorporating approved changes into the cost forecast.
  • Interaction with other Project organizations including the Engineer, Wyeth Procurement (Site & Global), WMI Finance, and Wyeth Global Engineering Services (GES) Project Management Team.
  • Contingency Management – Identify project critical deliverables, including identification of cost impact items, management of contingency, identification of float on critical activities and provision of solutions to minimize and/or eliminate cost overruns and schedule slippages.
  • Estimating/Scheduling – Supervision of estimating, schedule management and invoice review personnel assigned to the Project and responsible for the Project deliverables.
  • Develop and maintain Corporate Capital Forecast reports for GES and WMI. On a monthly basis, update and issue CAPEX reports working in conjunction with the GES Project Manager.
  • Procurement – Ensure the project control requirements are properly defined within requests for quotations (RFQ) and proposals (RFP). Participate and support the bid tab process through the review, negotiation and recommendation of awards for purchase orders (PO) and contracts. Close interaction with Site and Global Procurement.
  • Monitor PO funding for all parties, Engineering, Subcontractor and Consultants. Negotiate, forecast and issue PO revisions as necessary.
  • Verification and recommendation of Engineer, Subcontractor and GES Consultant progress payment requests.
  • Participate in regular Project coordination / review meetings with Project Team.
  • Earned Value measurement. Monitoring of physical performance and progress on site.
  • Benchmarking and collation of cost data information.
  • Supervising and carrying out ‘one-off’ specific tasks. These include audits for Engineering, invoice reconciliation and earned value.

Qualifications:

  • A minimum of a bachelor’s degree or equivalent is required.
  • Degree in communication is a bonus.
  • Prior experience as a team leader and impressive leadership talent.
  • Should also possess at least a basic understanding of computers and technology.
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Principal Project Engineer / Project Manager

Summary

Proven ability to accomplish projects independently, provides technical leadership for projects and/or programs of major significance to the Company, assuring that projects or initiatives are in alignment with site and business goals and strategies. Provides significant contributions on project teams and leads multi-functional teams. Demonstrates the ability to successfully plan complex engineering and technology projects and sustain high quality engineering and technology contributions. Provides recognized expertise in engineering/technology methodologies, and in developing approaches for successful project completion. Interfaces with all company groups and key business partners. Proactively looks for and recommends improvements in site processes and procedures. Recognized as a leader, giving significant technical direction and mentoring/training to junior staff.

Responsibilities

  • Assures major projects or initiatives are in alignment with site and business goals and strategies. Proactively looks for and recommends improvements in site processes and procedures. Leads conceptual studies for site capacity analysis and efforts for support of new product launches.
  • Applies expert knowledge and experience in relevant subject areas that is acknowledged both inside and outside of the Company. Makes major intellectual contributions to the engineering/technology direction of a project or team.
  • Works on or initiates projects or programs that are complex and have considerable technical risk. Provides significant contributions on project teams and leads multi-functional teams addressing major or multi-site projects. Coordinates information across project teams to facilitate project execution. Effectively communicates plans for novel programs or project ideas or engineering/technology directions both internally and externally.
  • Assumes complete technical responsibility for a project area. Provides recognized expertise in engineering/technology methodologies, and in developing approaches for successful project completion. Manages, coordinates and oversees development of project design documents. Communicates and applies thorough knowledge of relevant site processes, equipment and facilities. Maintains cognizance of the state-of-the-art in the industry to assure the company utilizes current technology.
  • Exemplifies cGMP compliance within the workplace by following and promoting site cGMP procedures. Incorporates cGMP and regulatory compliance into all assigned activities. Provides safety leadership within the workplace by following and improving site safety procedures. Proposes new methods for increased compliance.
  • Reviews major project estimates for design, equipment, installation, labor, materials, and other related costs. May prepare project forecasts and schedules and tracks costs. Participates in site capital planning process.
  • Reviews construction, installation, and commissioning work to ensure conformance to established site procedures, specifications, and industry standards.

Qualifications

  • BS +15 years Engineering Degree or MS +12 years
  • BS +18 years Non-Engineering Science Degree or MS +16 years
  • Requires technical, safety and cGMP compliance training
  • Demonstrated track record of increasing professional responsibilities
  • Minimum 12 years experience in project management of capital projects, plus two (2) significant projects, defined as costing $25M or more.
  • Minimum 12 years engineering experience in a pharmaceutical/biotech environment. Incumbent must demonstrate having an understanding of pharmaceutical/bio-technology industry along with technical proficiency.
  • Strong organizational, interpersonal, oral and written communication skills
  • Prioritizing multiple commitments and technical problem solving ability
  • Ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.
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Process Technician

Summary

Center for Breakthrough Medicines is seeking an experienced Process Technician to operate and maintain or repair systems and equipment to ensure uptime and reliability, regulatory compliance and overall department work performance goals. Ensure quality and safety standards are met and the maintenance operations are efficient and reliable. Maintain process systems and equipment at the highest level of reliability, compliance and cleanliness and ensure operating procedures and maintenance work orders are executed in accordance with all regulations.

Responsibilities

  • Maintain all equipment and systems in a state of readiness matching the needs of the business.
  • Focus skills and work practices on Processing Equipment, such as Bioreactors, Filtration systems, CIP/SIP Systems, Analytical Equipment, Flow Equipment, and Pumps and Valves.
  • Focus skills and work practices on Electrical and Instrumentation Systems, such as MCC’s, motors, motor starters, PLC’s or other controllers, relays, solenoids, and DDC equipment.
  • Assist with skills and work practices on Building Ops and Systems used throughout the facility, such as AHU’s, CS and MES generation and distribution, Compressors, and Life Safety systems.
  • Execute all work activities with area owner’s knowledge and follow-up through completion by self, other technicians or outside contractors, while ensuring business continuity, cGMP compliance, equipment serviceability and reliability.
  • Interact with area customers in a professional manner to apprise them of the situation, ongoing status, and results achieved.
  • Resolve problems while maintaining compliance with cGMP or cGLP requirements.
  • Report findings or work results to department management, as necessary.
  • Assist in the investigation of any deviations or atypical events as needed.
  • Review and close completed work orders in the department CMMS.
  • Develop procedures for work methods to sustain or improve the equipment or processes as requested.
  • Exhibit a comprehensive formal and informal demeanor to promote a positive work environment and promote an overall professional interaction with the facility working groups.
  • Review personal performance regularly and develop self within operating functions to continually enhance individual and overall work team performance.
  • Provide periodic reports on operating metrics and improvement initiatives.
  • Ensure all maintenance is completed properly and on time and that a record of completion is kept.
  • Requisition repair materials and equipment as required for the maintenance of process systems.

Qualifications

  • High School diploma, and Recognized Trade/Vocational school or equivalent military/construction trades training or apprenticeship.
  • 5 years of journeyman level experience in a technical trade such as HVAC-R, I/E&C, Building Ops, or Maintenance or Construction Trades.
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I/E&C Technician

Summary

Center for Breakthrough Medicines is seeking an experienced I/E&C Technician to operate and maintain or repair systems and equipment to ensure uptime and reliability, regulatory compliance and overall department work performance goals. Ensure quality and safety standards are met and the maintenance operations are efficient and reliable. Maintain process systems and equipment at the highest level of reliability, compliance and cleanliness and ensure operating procedures and maintenance work orders are executed in accordance with all regulations.

Responsibilities

  • Maintain all equipment and systems in a state of readiness matching the needs of the business.
  • Perform calibrations on lab and production equipment, including but not limited to Temperature, Pressure, Conductivity, CO2, Humidity, etc.
  • Focus skills and work practices on Processing Equipment, such as Bioreactors, Filtration systems, CIP/SIP Systems, Analytical Equipment, Flow Equipment, and Pumps and Valves.
  • Focus skills and work practices on Electrical and Instrumentation Systems, such as MCC’s, motors, motor starters, PLC’s or other controllers, relays, solenoids, and DDC equipment.
  • Ability to test and troubleshoot systems up to 480VAC.
  • Assist with skills and work practices on Building Ops and Systems used throughout the facility, such as AHU’s, CS and MES generation and distribution, Compressors, and Life Safety systems.
  • Execute all work activities with area owner’s knowledge and follow-up through completion by self, other technicians or outside contractors, while ensuring business continuity, cGMP compliance, equipment serviceability and reliability.
  • Interact with area customers in a professional manner to apprise them of the situation, ongoing status, and results achieved.
  • Resolve problems while maintaining compliance with cGMP or cGLP requirements.
  • Report findings or work results to department management, as necessary.
  • Assist in the investigation of any deviations or atypical events as needed.
  • Review and close completed work orders in the department CMMS.
  • Develop procedures for work methods to sustain or improve the equipment or processes as requested.
  • Exhibit a comprehensive formal and informal demeanor to promote a positive work environment and promote an overall professional interaction with the facility working groups.
  • Review personal performance regularly and develop self within operating functions to continually enhance individual and overall work team performance.
  • Provide periodic reports on operating metrics and improvement initiatives.
  • Ensure all maintenance is completed properly, safely and on time and that a record of completion is kept.
  • Requisition repair materials and equipment as required for the maintenance of process systems.

Qualifications

  • High School diploma, and Recognized Trade/Vocational school or equivalent military/construction trades training or apprenticeship.
  • 5 years of journeyman level experience in a technical trade such as HVAC-R, I/E&C, Building Ops, or Maintenance or Construction Trades.
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Maintenance Supervisor

August 18, 2022

Summary

Center for Breakthrough Medicines is seeking an experienced Maintenance Supervisor to ensure employee engagement, regulatory compliance and implement the department work performance goals. Oversee department specific operations to ensure quality and safety standards are met and the maintenance operations are efficient and organized. Maintain facilities in highest level of compliance and cleanliness and ensure operating procedures and maintenance work orders are executed in accordance with all regulations.

Responsibilities

  • Maintain all equipment and systems in a state of readiness matching the needs of the business.
  • Schedule all work activities with area owners and follow-up through completion by technicians or outside contractors, while ensuring business continuity, cGMP compliance, equipment serviceability and reliability.
  • Interact with area customers in a professional manner to apprise them of the situation, ongoing status, and results achieved.
  • Resolve problems while maintaining compliance with cGMP or cGLP requirements.
  • Report findings or work results to department management, as necessary.
  • Assist in the investigation of any deviations or atypical events as needed.
  • Review and close completed work orders in the department CMMS.
  • Develop procedures for work methods to sustain or improve the equipment or processes.
  • Provide comprehensive formal and informal leadership to promote a positive work environment and communicate overall business expectations to the plant working groups.
  • Prepare and communicate operational objectives to achieve department strategy, specifically around quality, safety and operational efficiency.
  • Review operating staff performance regularly and develop individuals within operating functions to continually enhance individual and overall work team performance.
  • Develop and provide periodic reports on operating metrics and improvement initiatives.
  • Coordinate routine and emergency maintenance of building and equipment.
  • Maintain up to date schedule of all routine maintenance and descriptions of required work.
  • Ensure all maintenance is completed properly and on time and that a record of completion is kept.
  • Requisition repair materials and equipment as required for the maintenance of facilities
  • Perform work evaluations for department staff as defined by the HR department.

Qualifications

  • High School diploma, and Recognized Trade/Vocational school or equivalent military/construction trades training or apprenticeship.
  • 15 years of journeyman level experience in a technical trade such as HVAC-R, I&C, Building Ops, or Construction Trades or 5 years prior management experience.
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Maintenance Technician – 3rd Shift

Summary

Responsibilities

· Responsible for the daily support of building infrastructure and systems

· Supports the Facility team engaged in maintaining building infrastructure, services, security, and grounds

· Monitors work order system and executes

· Works with the Engineering team to plan and implement equipment, systems and facilities modifications

· Create and maintain relationships within CFBM to develop and promote best practices and ensures compliance with SOP’s, safe work practices, and cGMP regulations

· Collaborate closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities

Coordinates support from site facilities manager for infrastructure and core utilities

Qualifications

· 5+ years of experience in a GMP facilities/manufacturing environment

· 2+ years of experience in a functional maintenance or calibration leadership role

· Direct experience supporting building facilities and utility systems within a manufacturing/production environment is desirable

· Understanding of local and state regulations and permitting

· Experience with the following unit operations or technologies: HVAC design and operations, electrical distribution, compressed gases, clean utilities (steam & WFI), Building Management Systems (BMS)

· Extensive knowledge in all disciplines of construction, especially GMP utility and cleanroom design/installation and quality control laboratory design/installation

· Strong understanding of industry standards for equipment qualification, maintenance, calibration, and operation of facilities and utilities for cGMP manufacturing and GXP laboratories

· Strong interpersonal and communications skills; written and oral

· Previous proficient experience with CMMS software system(s)

· Knowledge of OSHA and EPA regulations

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Maintenance Technician – 2nd Shift

Summary

Responsibilities

· Responsible for the daily support of building infrastructure and systems

· Supports the Facility team engaged in maintaining building infrastructure, services, security, and grounds

· Monitors work order system and executes

· Works with the Engineering team to plan and implement equipment, systems and facilities modifications

· Create and maintain relationships within CFBM to develop and promote best practices and ensures compliance with SOP’s, safe work practices, and cGMP regulations

· Collaborate closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities

Coordinates support from site facilities manager for infrastructure and core utilities

Qualifications

· 5+ years of experience in a GMP facilities/manufacturing environment

· 2+ years of experience in a functional maintenance or calibration leadership role

· Direct experience supporting building facilities and utility systems within a manufacturing/production environment is desirable

· Understanding of local and state regulations and permitting

· Experience with the following unit operations or technologies: HVAC design and operations, electrical distribution, compressed gases, clean utilities (steam & WFI), Building Management Systems (BMS)

· Extensive knowledge in all disciplines of construction, especially GMP utility and cleanroom design/installation and quality control laboratory design/installation

· Strong understanding of industry standards for equipment qualification, maintenance, calibration, and operation of facilities and utilities for cGMP manufacturing and GXP laboratories

· Strong interpersonal and communications skills; written and oral

· Previous proficient experience with CMMS software system(s)

· Knowledge of OSHA and EPA regulations

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