Senior Manufacturing Engineer — Documentation & Risk

Katalyst CRO; Manchester (NH); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO seeks a Senior Manufacturing Engineer to support manufacturing operations through process improvement, technical documentation, and risk management in a regulated production environment.

This role emphasizes revising and maintaining SOPs, work instructions, and process docs, with a strong focus on risk assessment using PFMEA/DFMEA and validation activities (IQ, OQ, PQ). Experience with CSV is a plus in a high-volume setting.

Qualifications

• Experience in regulated manufacturing environments with emphasis on process integrity and traceability.
• Ability to revise and maintain manufacturing documentation (work instructions, SOPs, process docs).
• Experience applying PFMEA/DFMEA risk methodologies.
• Experience with IQ/OQ/PQ in manufacturing validation.
• Exposure to high-volume bottling or filling equipment is desirable.

Responsibilities

• Revise and maintain manufacturing documentation to ensure accuracy and compliance with current practices.
• Identify and manage operational risks using structured risk methods (PFMEA/DFMEA).
• Support process validation activities (IQ/OQ/PQ) and TMVS documentation.
• Collaborate with cross-functional teams to ensure robust process controls in a regulated environment.

Skills

Analytical skills

Documentation

Risk management (PFMEA/DFMEA)

Process validation (IQ/OQ/PQ)

Regulated manufacturing experience

CSV familiarity

Tools

CSV

Job description

Katalyst CRO seeks a Senior Manufacturing Engineer to support manufacturing operations through process improvement, technical documentation, and risk management in a regulated production environment.

This role emphasizes revising and maintaining SOPs, work instructions, and process docs, with a strong focus on risk assessment using PFMEA/DFMEA and validation activities (IQ, OQ, PQ). Experience with CSV is a plus in a high-volume setting.