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.
Senior Process Engineer in charleston at Unknown Company
This position is listed as full time and onsite.