The manufacturing engineer is responsible for cGMP engineering support of Operations. Process engineering lead for developing cleaning development strategy and perform risk assessment and gap analysis for site cleaning programs.
Develop the cleaning and steaming strategy of stainless steel fixed tanks, portable tanks, polyethylene containers. Qualify lab washer and autoclave. Experience with evaluating detergents and CIP chemicals for proteins on stainless steel, glass or plastics.
- Planning and execution of cleaning validation program, including process monitoring, compliant with FDA and ISO requirements.
- Develop user requirement specifications and operational SOPs for cleaning of process equipment.
- Act as process engineering lead for developing cleaning development strategy.
- Perform risk assessment and gap analysis for site cleaning programs with laboratory washers and portable CIP systems.
- Risk rank cleaning remediations and generate action plan to correct priority items
- Create cleaning cycle development strategies for a variety of equipment including: fixed tanks, portable tanks, valves, pumps and labware.
- Perform spray coverage testing, cleaning verification/validation swabbing, and review of QC results.
- Perform piping design and flow calculations for CIP systems.
- Perform batch record review, including verifying calibration and in-process data.
- Perform commissioning and provide automation support for CIP systems, including PLC systems
- BS degree or higher in chemical engineering or a related engineering or scientific discipline.
- A minimum of 5 to 10 years industry (Biotechnology, Medical Device, or Pharmaceutical) experience.
- Familiarity with cleaning of process equipment, including CIP cycle development and optimization, piping design, and fluid dynamics.
- Familiarity with sanitization or sterilization of process equipment.
- Familiarity with plant control software, including PLC..
- Familiarity with engineering project management.
- Proven experience with: CIP cycle development, cleaning validation, protocol development, execution, troubleshooting, and summary reports.
- Strong verbal and written communication skills.
- Industry experience related to cGMP manufacturing, validation, programming, or chemical process design.
- Strong computer knowledge including Microsoft Office products.
Non-Negotiable Hiring Criteria
- This position does not offer Relocation Assistance.
- Bachelor’s degree with minimum of 5 years of post-degree experience.