5-7 years of experience in manufacturing engineering
Strong analytical and documentation skills
Experience in regulated manufacturing environment
Familiarity with PFMEA and DFMEA methodologies
Processes validation knowledge (IQ, OQ, PQ)
Experience with CSV (desirable)
Exposure to automated production lines (preferred)
Responsibilities
Support manufacturing operations with process improvement and risk management
Revise and maintain manufacturing documentation for compliance
Identify and manage operational risks using structured methodologies
Conduct process validation activities across operational risks
Contribute to cross-functional operational risk assessments and TMVS documentation
Benefits
Opportunity to work in a regulated production environment
Involvement in process validation and improvement activities
Potential for career growth in manufacturing engineering
Collaboration with cross-functional teams
Utilization of advanced risk management techniques
Full 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.
