Senior Process Engineer

The Senior Process Engineer will provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to equipment lifecycle, qualification, audit responses, and validation to meet regulatory requirements. Shall have excellent oral/written communication skills and strong technical writing ability to lead and/or participate on teams with internal partners, customers, and vendors. Additionally, the candidate must thoroughly understand and be able to adapt to the changing needs of a contract manufacturing environment. **Essential Job Functions:** • Monitor and analyze manufacturing data as necessary to provide support for process improvement and investigations. • Participate and support process FMEAs to understand process and product risks as a pre-requisite for process validation. • Mentor and train other team members. • Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues. • Lead and ensure systematic DMAIC based approach utilization for process/product related investigations to identify root cause and provide impact assessment to maintain routine manufacturing operations and determine process improvements for manufacturing. • Participate and report to a cross-functional team to advance production activities. • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing. • Write technical documentation (protocols & reports for equipment/instrument qualifications, comparability, process, and manufacturing process validation testing) • Execute engineering studies, recipe development, and validation test cases. • Work with vendors and suppliers to define requirements and understand functional specifications. • Understand manufacturing needs and adapt to the changing needs of the manufacturing environment. • Work flexible hours for the coverage of the production facility. **Special Job Requirements:** • Sterile Injectables (Formulation, aseptic filling, inspection, and/or packaging) • Knowledge of data management tools and RCM. • Bachelor’s degree or higher in engineering, bioengineering, or related scientific field. • 10+ years’ experience in biopharmaceutical or other GXP regulated industry. **Additional Preferences:** • CMO/CDMO experience • Technical and/or lean six sigma certifications • Electro-mechanical practical experience