Sr Manufacturing Engineer

Katalyst Healthcares & Life Sciences
  • Manchester, NH
  • Quick Apply
30+ days ago

Job Description

Roles & Responsibilities:
  • Our client is seeking a Senior Manufacturing Engineer to support manufacturing operations through process improvement, technical documentation, and risk management activities within a regulated production environment.
  • This role will focus heavily on revising and maintaining manufacturing documentation, including work instructions, standard operating procedures (SOPs), and process documentation, ensuring accuracy, compliance, and alignment with current production practices.
  • The engineer will play a key role in identifying and managing operational risks through structured risk management methodologies such as PFMEA and DFMEA, with a strong emphasis on defining and analyzing critical process inputs and outputs to support robust process controls.
  • In addition to core manufacturing engineering responsibilities, the role will support process validation activities (IQ, OQ, PQ) and contribute to cross-functional efforts related to operational risk assessments and TMVS documentation.
  • Experience with CSV is considered a plus. The ideal candidate will bring strong analytical and documentation skills, along with experience supporting regulated manufacturing environments where process integrity and traceability are critical.
  • Exposure to high-volume bottling or filling equipment is highly desirable, though not required, and candidates with experience supporting automated or high-throughput production lines.

Numbers & Facts

LocationManchester, NH

Skills

  • Analysis Skillsunmatched
  • Cross-Functionalunmatched
  • Design Failure Mode and Effects Analysis (DFMEA)unmatched
  • Documentationunmatched
  • High Throughputunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Operational Auditunmatched
  • Operational Supportunmatched
  • Operations Managementunmatched
  • Operations Processesunmatched
  • Process Analysisunmatched
  • Process Control Engineeringunmatched
  • Process Failure Mode and Effects Analysis (PFMEA)unmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Production Systemsunmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Technical Writingunmatched
  • Traceabilityunmatched

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