The Process Engineer will provide support to Equipment and process Validation. Must have experienced with process design and be able to perform Process & Equipment Validations and Qualifications. Product Transfer for manufacturing area. In addition be able to review/perform process & equipment validations (IQ, OQ, PQ).The successful candidate must have experience in Quality Engineering areas for regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry.
- Plan, write, coordinate, execute, summarize, review process validation protocols.
- Validation, risk assessments, FAT, SAT, Commissioning, IQ, OQ, PQ,
- Deviations, results and approvals for Equipment and Tooling
- Product Transfer, IQ, OQ, PQ, Deviations, results and obtain approvals for New Sealer
- Provide support and approval for all documentation required for Component
- Qualifications and Test Methods for project components and End Items
- Provide support and approval for all documentation required for project deliverable
- Process & Equipment Validation and qualification
- Set-up of Incoming Inspection equipment, ensure satisfactory operation and inspections
- Generate new SOP'S
- Assist meetings and provide weekly reports when applicable
- Project planning and executing, as well as generate CRs for new document
- Assist in coordination of production steps for new product introduction to manufacturing
The Process Enineer requires minimum of 5+ years of experience in the pharmaceutical, Medical Device or other FDA regulated industry working with Process Design, Equipment Validation/Qualification and Process Validations.
The Process Engineer requires Bachelor Degree in Engineering
Integrated Technology and Compliance Services is an Equal Opportunity Employer