Contract manufacturing engineer
Job Title: Contract Manufacturing Engineer
Job Description As a Contract Manufacturing Engineer, you will be instrumental in equipment qualification, process validations, and documentation related to manufacturing processes and equipment integration. You will play a vital role in supporting three main production lines to ensure they are operational and ready for production. The position entails a 50/50 split between on-floor work and desk duties, subject to fluctuation. On the floor, you will set up processes, execute protocols, and perform testing for validation reports. At your desk, you will focus on writing protocols, preparing for studies, and completing various documentation tasks. Responsibilities- Qualify equipment and validate processes to ensure manufacturing readiness.
- Support the setup of new manufacturing processes and execute process protocols.
- Conduct testing to contribute to validation reports.
- Create and maintain comprehensive documentation, including CPK studies, engineering reports, and design of experiments.
- Develop device master records and set up process formulas.
- Create manufacturing assembly SOPs and work instructions for product lines.
- Collaborate with internal teams to ensure smooth operations and process efficiency.
- Bachelor's Degree in Engineering.
- Experience in equipment qualification and process validation.
- Proficiency in setting up new processes and Cpk (Process Capability).
- Strong background in engineering documentation (Design of Experiments and SOPs).
- Experience working within a structured QMS (ISO) or GMP/cGMP environment.
- Minimum of 3+ years of relevant experience preferred.
- PFMEA experience.
- Experience with product launches.
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
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