Engineer (Pharma/Biotech)

Gaithersburg, MD 20878

Posted: 05/14/2019 Industry: Other Area(s) Job Number: 35207

Engineer 1 (Pharma/Biotech Mfg)

This role is responsible for maintaining reliable process equipment performance in one or more manufacturing areas at 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. EXPERIENCE: 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


BS in Chemical Engineering

Experience working as an engineer supporting GMP biotech manufacturing or as a manufacturing tech supporting GMP biotech manufacturing preferred.

Schedule --- First Shift: 7: 30 am to 4: 30 pm, T

i REQUIRED SKILLS: • 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.
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