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Senior Manager Engineering - MTS

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PCI Pharma Services

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Location:
United States , Bedford

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Category:

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

The Sr. Manager Process Engineering of Manufacturing Technologies and Sciences (MTS), reports to the Director-MTS, and is responsible for providing leadership, technical management, and professional development for the MTS Engineering team as well as collaborating between MTS Process Specialists Team, MTS management, Project Management, Process Development, Purchasing, Validation, Quality, Safety & Manufacturing teams. A major responsibility for the Sr. Manager is to provide technical support and strategic direction to internal stakeholders and external clients, providing guidance to technical writing and decision making in the execution of the specific client project deliverables, all performed in a timely manner. The Sr. Managers’ actions support overseeing of Process Engineering into PCI manufacturing, plant floor operations (formulation/fill/finish/lyophilization), and development of manufacturing documentation supporting new product introduction.

Job Responsibility:

  • Lead and manage the Process Engineering team within MTS, including hiring, training, and development
  • Manage team to support the planning and execution of tech transfer/new product introduction projects
  • Support complex/challenging processes with unique equipment, componentry, processing requirements
  • Manage team to Identify and Implement new technologies and methodologies within the MTS function
  • Design/Review/Approve engineering drawings
  • Develop and execute comprehensive technical transfer plans
  • Support process characterization studies, process validation activities, and risk assessments
  • Support resolution of complex manufacturing issues and provide technical support of critical process-related deviations
  • Manage/Support the technology transfer of processes from internal and external development groups
  • Provide technical leadership and guidance to both internal and external requirements for defining scope, planning, scheduling resources and overseeing the MTS project support activities
  • Provide technical perspective during internal and external audits, regulatory inspections and due diligence
  • Facilitate tactical support of ongoing plant operations and strategic implementation of engineering projects
  • Interface directly with all clients to ensure highest level of customer satisfaction is achieved
  • Demonstrate and promote continuous improvement in efficiency, quality, and safety
  • Remain current with biopharmaceutical industry best practices, technologies and developments
  • Build and lead a team of process engineering experts
  • Key technical leadership for clinical/commercial stage programs including technology transfer, validation, process design, and manufacturing support
  • Develop and implement strategies for continuous improvement across manufacturing processes
  • Interpret manufacturing process data, identify trends, troubleshoot problems, and drive data-driven decision-making
  • Coordinate the preparation, review, and approval of technical documentation

Requirements:

  • Minimum of 14 years of technical experience within Life Sciences (Biopharmaceutical/Biotechnology), Medical Device or Aseptic Manufacturing Organization with GMP industry experience
  • BS/MS in chemical, mechanical, pharmaceutical engineering or relevant work experience
  • Strong hands-on experience in either Process Engineering/Sciences, Manufacturing Operations, or Technical Project Management
  • Prior people managing experience, supervisory experience at a minimum
  • Experience leading and driving large projects and initiatives to completion

Nice to have:

  • Prior lyophilization experience
  • Experience preferably in a biopharmaceutical or medical device manufacturing organization with familiarity with aseptic manufacturing

Additional Information:

Job Posted:
February 20, 2026

Expiration:
February 23, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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