Manages projects and coordinates shutdowns.
Supports new engineering projects. Creates project scopes, URS, and timelines
Performs troubleshooting, corrections, and process performance optimization
Monitors bioprocess equipment performance. Identifies equipment issues and helps develop technical solutions
Determines process requirements. Helps design, install, and commission new processes and equipment
Writes cGMP documentation (SOPs, change controls, validation protocols, etc.)
Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs.
Performs GMP change control activities.
Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans
Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy
Provides on-call support and works overtime as needed.
Prior GMP experience in a biotech or sterile pharmaceutical manufacturing environment a plus. Prior experience with production scale biotech process equipment a plus. Prior experience with Trackwise a plus.
Experis is an Equal Opportunity Employer (EOE/AA)