Reliability Engineering Manager
14 hours ago
PharmEng Technology Americas is seeking a seasoned Reliability Engineering Manager to join our team. As a key member of our engineering team, you will be responsible for ensuring the process and process equipment meet compliance, safety, and business requirements on a day-to-day basis.
The ideal candidate will have superior skills and experience in the optimization of procedure improvement and a willingness to work in a dynamic, on-site pharmaceutical project environment. You will be responsible for troubleshooting equipment to determine root cause of failure modes, owning Corrective/Preventative Actions & associated change controls, providing input on preventative maintenance plans, assessing change controls, and spearheading continuous improvement initiatives.
Key Responsibilities:
- Ensure process and process equipment meet compliance, safety, and business requirements.
- Troubleshoot equipment to determine root cause of failure modes.
- Own Corrective/Preventative Actions & associated change controls.
- Provide input on preventative maintenance plans.
- Assess change controls and spearhead continuous improvement initiatives.
- Maintain process equipment assets through CMMS.
- Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
- Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
- Acting as an owner, provide engineering support for process equipment procurement and start-up and CQV at Moderna's Norwood Clinical manufacturing facility.
- Participate on project teams through all phases of engineering projects related to process equipment.
Requirements:
- Bachelor's degree in Electrical or Mechanical Engineering or any other life science related technical field.
- Minimum of 10 years relevant experience as a Process Engineer or System Owner in a Drug Product manufacturing environment.
- 10-15 years of experience in a GxP environment preferred.
- Experience with Drug Product technologies (Aseptic Filling Line for vials and Syringes, Filling Isolator, Formulation, Analytical Equipment, Automatic Inspection, Label and Secondary Packaging, Compounding and Component Prep equipment such as Parts Washer and Autoclave).
We offer a dynamic and supportive work environment where empowerment, passion, and perseverance are nurtured. If you are a motivated and experienced Reliability Engineering Manager looking for a new challenge, please submit your application.
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