We are looking for a Quality Investigator to support and improve sterile filling processes in a cleanroom environment. This role focuses on leading equipment investigations, conducting risk assessments, and collaborating with various teams to optimize processes and ensure GMP compliance.

• Process Improvement: Enhance sterile filling operations and ensure compliance with cleanroom standards.
• Equipment Support: Work with engineering and manufacturing teams to improve cycle times, tool availability, and product yield while reducing costs.
• Tool Maintenance: Address and resolve equipment-related process issues.
• Documentation: Create and update operating procedures for production processes.
• Investigations: Lead equipment investigations and implement corrective actions using Change Control.
• Risk Assessment: Conduct Risk/Impact Assessments (PFMEA) to identify and mitigate process risks.
• Equipment Expertise: Hands-on work with Optima Washers, CIP/SIP systems, and Genesis Capper.
• Project Coordination: Support new product development, tech transfers, and testing for new processes.

• Experience: 3-5 years in a GMP pharmaceutical manufacturing environment.
• Problem-Solving: Experience with investigation tools like 5 Whys, Fishbone Analysis, and DMAIC.
• Technical Writing: Strong skills in writing reports, deviations, and SOPs.
• Software Skills: Proficient in MS Office (Word, Excel, PowerPoint).
• Communication: Excellent written and verbal skills, able to work with all levels of the organization.

• Experience with aseptic gowning and working in cleanrooms.
• Hands-on knowledge of filling line equipment and processes.