Job Title: Validation Engineer/Process Engineer
Client: Indivior
Location: 8900 Capitol Blvd, Raleigh, NC-27616
Job Duties:
- Review, develop and execute validation lifecycle documents like FAT, SAT and qualification protocols for new equipment and existing equipment enhancements & upgrades for sterile filling, device assembly, and packaging equipment.
- Develop aseptic filling, setup, disassembly, cleaning, and sanitization processes to ensure residues from equipment and cleaning chemicals do not cross contaminate into final filled products in accordance with 21 CFR part 211, 810, 811, FDA EMEA, and other regulatory & quality guidelines.
- The work also involves writing and updating Validation Plans, Change Controls, CAPAs and Risk Assessments through various stages of process validation and product launch activities.
- Develop, author, and modify Standard Operating Procedures (SOPs), Work Instructions (WIs), Manufacturing batch records (MBRs), and Preventative Maintenance (PM) plans for various sterile filling, device assembly, and packaging equipment.
- Lead validation activities and write technical reports such as study reports, validation reports, and mechanical shakedown runs, engineering studies, and feasibility development reports. Document and investigate/assist any deviations associated during the executions.
- Perform instrument and equipment qualification, analytical and microbial swab sampling, visual inspection during validation activities. Interpret and summarize the results obtained from the laboratory testing.
- Identify and analyze process activities to improve overall equipment efficiency, optimize process to increase batch size & capacity, improve yields, reduce waste, and streamline process flow, and overall process layout.
- Perform equipment, process setup, and cleaning activities in a team-oriented environment to align with cross functional departments such as production, planning and quality. The duty also involves training/assisting other production team members for timely completion of the projects.
Minimum Education Requirement:
Bachelor's degree in a relevant engineering discipline (chemical, mechanical, biomedical, etc), chemistry, pharmaceutical science or a related life sciences field.