Senior Process Engineer
Meet Life Sciences
The Senior Process Engineer provides technical support for clinical and commercial sterile/parenteral drug product manufacturing. The role focuses on process tech transfer, validation, troubleshooting, investigations, and manufacturing documentation in a cGMP-regulated environment. Responsibilities Support process tech transfers, validation activities, and manufacturing projects. Author Master Batch Records and process validation documentation. Provide technical troubleshooting support during manufacturing operations. Lead manufacturing investigations and CAPA activities. Develop CQA assessments, pFMEA risk assessments, validation protocols, and sampling plans. Coordinate laboratory studies with formulation development teams. Partner with internal stakeholders and clients on project activities. Ensure compliance with cGMP, FDA, EU, SOP, and batch record requirements. Qualifications Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field. 5+ years of technical support experience in sterile pharmaceutical manufacturing. Experience with parenteral drug product tech transfers preferred. Strong knowledge of cGMP requirements and sterile manufacturing processes. Strong technical writing, troubleshooting, analytical, and communication skills. Proficiency with Microsoft Office. Willingness to work fully on-site and travel up to 5% domestically. #J-18808-Ljbffr
Vacancy posted 13 hours ago
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