GlaxoSmithKline Process/Equipment Engineer in Philadelphia, Pennsylvania
Open date:Oct 12, 2017 4:46 PM
King of Prussia,
Required degrees:Bachelor of Engineering
Experience required:1 year
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Basic qualifications:• 1+ years pharmaceutical engineering experience and exposure to GMP manufacturing facilities.
• BS Engineering degree
• Broad-based knowledge of Biopharmaceutical processing and analytical equipment, and associated engineering, and maintenance activities.
• Familiarity with a computerized maintenance management system (CMMS).
• Knowledge of GMP Utility Systems (Water for Injection, Clean Steam, HVAC).
• Familiar with process instrumentation, PLC and Distributed Control Systems, with specific experience in Microbial and Mammalian Cell Culture production, protein purification operations, and utility systems.
• Experience with subcontracted and external projects to perform project deliverables. Lead and participate in the execution phase of these projects.
• Experience in biotechnology process equipment and/or facilities design and specification.
• Knowledge of cGMP guidelines for pharmaceutical processing.
• Demonstrated record of achievement in small project execution, cross-functional team contribution and equipment troubleshooting.
• Represent the Engineering department on teams requiring relevant primary experience
• Prioritization and self-directed coordination of engineering and maintenance activities.
• Proactively interact with related groups including all Biopharm Process Development Groups, Site engineering and maintenance, Quality Assurance, Document Control, and Validation
Preferred qualifications:As above
• Facilitates interaction within and between Biopharm R&D departments and GSK’s site engineering. The R&D departments include GMP Operations, Process Development, Clinical Active Supply (manufacturing), QA, QCC, Validation and Document Control.
• Supply equipment engineering support to the clinical manufacturing and process development groups that work on Microbial and Mammalian Cell Culture processes and their associated analytical methods. Work closely with scientific and manufacturing groups to understand procedures and process steps from vial thaw and seed scale-up to small- scale production bioreactors and purification steps.
• Identify and report on facility, equipment and utility improvements, operational efficiency and/or cost saving opportunities within the Biopharm R&D community.
• Provide technical leadership for the specification, installation and commissioning of new capital equipment and upgrades to existing equipment as part of small capital projects. Project activities may include interaction with vendors and suppliers, performance of engineering evaluations for device selection and calculations for equipment sizing, Factory Acceptance Tests and equipment inspection.
• Support GMP facility walk throughs to proactively identify facility issues and drive timely resolution.
• Work closely with the Technology Transfer groups during product change-over and identify and resolve any operational challenges presented by new compounds and/or manufacturing methods.
• Develop and/or improve equipment and procedure documentation including Functional Requirement Specifications, Standard Operating Procedures and engineering documentation maintenance procedures among others.
• Responsible for establishing and managing maintenance and calibration schedules for R&D equipment and instrumentation.
Deadline for applications: 23rd October 2017
You may apply for this position online by selecting the Apply now button.
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