Engineering Technician

Pyramid Consulting, Inc
Gaithersburg, MD
Sep 24, 2021
Sep 26, 2021
Full Time
Immediate need for a Job title ETS Engineer I e xperience in the Pharmaceutical Industry . This is 6+ Months Contract position for the location Gaithersburg , MD. Please review the job description below: Job ID #21-52332 Title: ETS Engineer I Location:MD; Gaithersburg Duration: 6 Monthscontract with possible extensions Schedule:First Shift: 7:30 am to 4:30 pm, but the exact hours are negotiable Job Description: Ideal Candidate Profile: -The ideal candidate would have a BS in Chemical Engineering and a few years of experience working as an engineer supporting GMP biotech manufacturing. -The HM would possibly be open to candidates who have a BS in Chemical Engineering and working experience as a manufacturing tech supporting GMP biotech manufacturing. -The HM would also be open to a recent Chem Engineering graduate looking for their first engineering job. If they don't have any professional experience, then some relevant summer internships or co-ops would be helpful. Scope of Role: Engineer to work in Engineering Technical Services (ETS) as a process equipment SME, supporting clinical manufacturing in Manufacturing Sciences (MS) in Gaithersburg. Job Description: This position reports to a Senior Engineer in Engineering Technical Services supporting GMP clinical biomanufacturing. Responsible for maintaining reliable process equipment performance in one or more manufacturing areas at Client's 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. 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 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. Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration. #Mor

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