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We're looking for a Process Engineer III
, working in Pharmaceuticals and Medical Products
industry in 1 Research Drive, Westborough, Massachusetts, 01581, United States
- Be the technical expert on all product related issues and ensure sites adhere to GMP and regulatory guidelines.
- Ensures the technical support for the Change Control system implemented between the company and sub-contractors assuring a relevant management for proposed changes on processes, equipment, and product feature functions
- Troubleshoots manufacturing issues and provide solutions leading to product releases.
- Provides technical support for all products manufactured externally at third party contract manufacturers, North American locations.
- Works closely with the QA department, help consolidate the overall product quality indicators and initiate technical action plans in case of issues.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- BS/MS/PhD in Pharmacy, Engineering, or Chemistry with 10+/7+/3+ years of industry experience as described below
- Firsthand experience in different stages of Pharmaceutical Technical Operations under cGMP and regulated environment
- 3 + years of experience in pharmaceutical or biotech manufacturing technical Services/tech support or engineering function under cGMP environment
- Experience with 3rd party manufacturing technical services support function and plant operations will be preferred
- Strong time management and prioritization skills
- Effectively communicate at all levels of associates in the Sanofi organization (from operator to vice president) or supplier and customer at all level (including CEO)
- Thorough knowledge of GMPs and regulatory requirements with respect to validation engineering and development of pharma products (including Sarbanes Oxley)
- Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations
- Project management skills
- Thorough understanding and knowledge of product manufacture, formulation, quality, regulatory, technical transfer, process development and validation
- Skilled in improving productivity, cost analysis, plant equipment evaluation and maintenance
- Demonstrated talent for building and managing smooth-running - cost effective production and plant operations
- Thorough understanding and knowledge of Oral Solid, Semi Solid, and sterile product lines from early phase development to commercialization
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?