This position reports to the Associate Director of Engineering Technical Services supporting GMP clinical biomanufacturing. Responsible for maintaining reliable process equipment performance in one or more manufacturing areas at MedImmunes Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.
- Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment in assigned area(s)
- Resolves daily operational issues in assigned area(s)
- 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. Candidates without a BS in engineering require a minimum of 2-years of experience in GMP biotech manufacturing
- Good at trouble shooting and problem solving.
- Good oral and written communication skill, and good admin skills
- Good interpersonal skills
PROBLEM SOLVING COMPLEXITY:
Works on routine technical problems of limited scope and complexity.
IMPACT: Completes many routine tasks and helps contribute to the completion of some non-routine tasks Contributes to completion of milestones for specific projects.
- Failure to achieve results or erroneous decisions may cause delays or product loss.
FREEDOM TO ACT:
- Works with moderate supervision, and usually follows established procedures.
- Receives training on routine work and detailed instruction on new assignments
- Often troubleshoots equipment problems and may perform corrections outside of established procedures.
Engineering Technician (General)