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Process Engineer III
Ref No.: 19-07619
Location: Bridgewater, New Jersey
Process Engineer III 
Biopharmaceutical Industry
Bridgewater, NJ 08807

Pay: $71.07 / hour
Schedule: 8 hours/day, 5 days/week, 40 hours/week

Join a global biopharmaceutical company committed to healthcare solutions from prevention to treatment.  They turn scientific discoveries into medicine to improve human health.  Every day they dedicate their most important resource, the people, to support patients and families through their health journey.


We are searching for a Process Engineer III who will have the following Key Role and Responsibilities:
  • Serves as an in‐house pharmaceutical process expert to support Industrial Development plans for new products, product line extensions and manufacturing site technical transfers of commercial products
  • Oversee technical services activities and engineering at third party manufacturing sites (CMOs) and ensure compliance with Good Manufacturing Practices
  • Interact with North American Industrial Development, External Manufacturing, Regulatory and Quality teams in addition to third party manufacturing sites, and sites outside the US which manufacture all dosage forms including oral dosage, semi‐solids, liquids, injectables and lyophilized for numerous global markets
  • Work with and manage third party technical activities and ensure tech transfer activities are performed according to cGMP
  • Act as the technical expert on all product formulation / process related technical issues and ensure sites adhere to GMP and regulatory guidelines
  • 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.
  • Transfer new and existing products from manufacturing sites to others with no interruptions
  • Troubleshoot manufacturing issues and provide solutions leading to product releases
  • Review, execute and support validation activities at third party contractors
  • Work with Regulatory teams to support product submissions to the FDA
  • Ensure the technical support for the Change Control system implemented between organization and the sub‐contractors assuring a relevant management for proposed changes on formulation, processes and equipment
Skills
  • Thorough knowledge of cGMP’s and regulatory requirements with respect to development, engineering and validation of pharma products
  • Understanding of various drug product manufacturing including oral dosages, semi‐solids, liquids, injectables, lyophilized and medical drug/device combinations
  • Knowledge of API manufacturing a plus
  • Thorough understanding and knowledge of product manufacture, formulation, quality, regulatory, technical transfer, process development and validation
  • Thorough understanding and knowledge of oral solid, semi‐solid, and sterile product lines from early phase development to commercialization
  • Effectively communicate at all levels of associates in the Sanofi organization or supplier and customer at all levels
  • Project management skills
  • Skilled in improving productivity, cost analysis, plant equipment evaluation
Education:
  • Bachelor of Science, Pharmacy, Engineering, or Chemistry
  • 8 ‐ 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 Power point are necessary
  • Knowledge of French language (speak, read and/or write) a plus