Manufacturing Process Engineer will identify and mitigate production issues in aseptic filling and related operations through process improvement and engineering methods. The role focuses on optimizing existing processes, leading equipment qualification and validation activities, and supporting manufacturing teams at a pharmaceutical contract manufacturing facility.
Responsibilities
- Support technical activities for new and existing products including process optimization, troubleshooting, and validation
- Gather and analyze manufacturing data to minimize waste, variability, and improve yield and efficiency
- Write standard operating procedures, standard test procedures, batch records, and GMP documentation
- Lead commissioning of equipment including change controls, FAT/SAT activities, and staff training
- Lead manufacturing investigations and corrective action initiatives; approve validation protocols as needed
Requirements
- 3-6 years pharmaceutical cGMP manufacturing experience or equivalent education/experience combination
- Experience with parenteral processing equipment including filling, visual inspection, and packaging
- Ability to lead teams through FAT, SAT, IQ/OQ, and engineering batch activities
- Strong data-driven root cause analysis and continuous improvement experience
- Intermediate to advanced computer skills for aseptic filling isolator operation and support systems
- Ability to explain complex technical concepts to external customers and regulatory agencies
- Proficient written and verbal communication skills at professional level
Manufacturing Process Engineer in bedford at Unknown Company
This position is listed as contract and onsite.