Production Engineer - GMP MFG Equipment
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Major pharmaceutical R&D and manufacturing organization seeks Engineer to support GMP manufacturing operation. This position reports to the Associate Director of Engineering Technical Services supporting GMP clinical manufacturing. Responsible for maintaining reliable equipment performance in one manufacturing area at Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.
-Subject Matter Expert (SME) manufacturing equipment in assigned area
-Resolves daily operational issues in assigned area
-Performs troubleshooting, maintenance, and process performance optimization
-Installs or replaces components and equipment.
-Supports shutdown and return to service activities
-Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans
-Coordinates maintenance activities with Facilities / Coordinates service contracts and work of outside vendors.
-Obtains quotes and purchases spare parts and equipment, and adds parts to the SAP inventory system
-Monitors 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, MPRs, protocols, etc.)
-Writes other documentation including: user requirements, specifications, protocols, HECPs, drawings, and reports
-Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs.
-Performs GMP change control activities.
-Instructs staff on process/system integration and operation. Develops training plans.
-Supports new engineering projects. Creates project scopes, URS, and timelines
-Represents Manufacturing and Engineering Services on equipment projects managed by other engineering groups
-Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy
-Evaluates new equipment technologies. Participates in tech transfers
-call support and works overtime as needed.
-Often troubleshoots equipment problems and may perform corrections outside of established procedures. EDUCATION:
-Bachelor’s degree in Engineering (Chemical Engineering preferred) or Life Sciences. (Other candidates with extra experience may be considered) EXPERIENCE:
-Prior GMP experience in a biotech or sterile pharmaceutical manufacturing environment a plus.
-Prior experience with production scale biotech equipment a plus.
-Candidates without a BS in engineering require a minimum of 2
-years of experience in GMP biotech manufacturing REQUIRED SKILLS:
-Good at trouble shooting and problem solving.
-Good oral and written communication skill, and good interpersonal skills
-Good interpersonal skills