Process Engineer
Posted
Responsibilities:
- Provide technical support for all products manufactured externally at third party contract manufacturers, North American locations. Frequent visits to third party sites for batch monitoring are required.
- Act as the technical expert on all product formulations, scale-up activity, process validation, equipment qualification, process related technical issues and investigations to ensure sites adhere to GMP and regulatory guidelines.
- Review and/or author technical protocols, reports or memos.
- Lead Continued Process Verification (CPV) activities across Contract Manufacturing Organizations (CMOs).
- This includes overseeing data collection and analysis, ensuring ongoing process performance and control, partnering with CMOs to identify and mitigate risks, and driving continuous improvements to strengthen product robustness.
- The role will collaborate closely with Quality, MSAT, and CMO technical teams to ensure compliance with regulatory expectations and maintain a state of control throughout the product lifecycle.
- Support manufacturing tech transfer of new and existing products.
- Support multi-functional teams to formulate plans and strategy that meet defined objectives.
- Troubleshoot manufacturing issues, conduct effective problem-solving and provide solutions leading to product releases.
- Review, execute and support validation activities at third party contractors.
- Work with Regulatory teams as needed to support product submissions to the FDA.
- Bachelor of Science, Pharmacy, Engineering, or Chemistry.
- 8 to 10+ years in Pharmaceutical Operations or Technical Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
- 10+ years in a Technical Services or engineering function.
- Experience in third party manufacturing, technical services support function and plant operations.
- Good knowledge and hands-on application of Word, Excel, and Powerpoint are necessary.
- Thorough knowledge of cGMP's and regulatory requirements with respect to development, engineering and validation of pharma products.
- Comprehensive knowledge of drug product manufacturing for solid and liquid oral dosages. Knowledge of API manufacturing a plus.
- Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
- Knowledge of product manufacture, formulation, quality, FDA and EMA regulations, technical transfer, process development and validation.
- Skilled in improving productivity, cost analysis, and plant equipment evaluation.
