5-7 years of experience in manufacturing engineering roles
Strong understanding of process improvement and documentation standards
Experience in regulated production environments
Proficiency in risk management methodologies like PFMEA and DFMEA
Analytical skills for defining critical process inputs and outputs
Familiarity with process validation activities (IQ, OQ, PQ)
Exposure to automated high-throughput production systems or equipment is a plus
Responsibilities
Support manufacturing operations through process improvement initiatives
Revise and maintain manufacturing documentation such as SOPs and work instructions
Identify and manage operational risks using structured methodologies
Contribute to process validation and operational risk assessments
Ensure compliance and alignment of documentation with production practices
Collaborate with cross-functional teams for TMVS documentation
Analyze manufacturing processes to ensure traceability and integrity
Benefits
Opportunity to work in a regulated and innovative manufacturing environment
Engagement in cross-functional projects and risk management
Possibility for professional development in process validation and compliance
Collaboration with skilled professionals in high-volume manufacturing
Consideration for candidates with specialized knowledge in CSV and automation technologies
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.
