Process Engineer Pharmaceutical Manufacturing Temp-to-Hire
Overview
Seeking a hands-on Process Engineer for a temporary position supporting oral solid dosage and sterile operations. The role involves driving process robustness compliance and continuous improvement in a dynamic pharmaceutical environment. This opportunity focuses on equipment qualification technology transfer and cross-functional collaboration.
What You'll Do8
- 1Plan execute and document Equipment Qualification IQ/OQ/PQ and process validation across OSD and sterile manufacturing
- 2Lead technology transfer activities for new products processes and equipment introductions
- 3Lead root cause investigations for deviations and out-of-spec results developing effective CAPAs
- 4Develop and maintain Continuous Process Verification programs monitoring critical process parameters and quality attributes
- 5Support aseptic manufacturing processes for injectable products including sterility assurance reviews and equipment qualification autoclaves filling lines isolators lyophilizers
- 6Identify and execute process improvement yield improvement and cost reduction projects while maintaining compliance
- 7Perform risk assessments using FMEA and apply statistical analytical tools for process monitoring
- 8Partner cross-functionally with engineering maintenance and QA to keep systems qualified
Requirements5
- 1Bachelor's or Master's degree in Chemical Mechanical or Pharmaceutical Engineering or related field
- 25-10 years of pharmaceutical manufacturing experience with demonstrated experience in OSD and exposure to sterile operations
- 3Proven hands-on experience with IQ/OQ/PQ and Technology Transfer
- 4Track record leading process improvement initiatives in a regulated pharma environment
- 5Working knowledge of cGMP ICH Q8-Q10 Annex 1 and 21 CFR 210/211
Salary Insight
$42k per year
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