| Job Description | Basic qualifications:
• 5 to 10 years pharmaceutical engineering experience and exposure to biopharmaceutical processing activities is required.
• Biochemical Engineering, Chemical, Mechanical, Electrical or equivalent 4-yr technical degree is required.
• Requires broad-based knowledge of Biopharmaceutical processing and analytical equipment, and associated engineering, and maintenance activities.
Preferred qualifications:
• Experience with the use of a computerized maintenance management system (CMMS).
• 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 leading the development of functional and detailed specification documentation for in-house, 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. Equipment knowledge of bioreactors & fermenters, filtration, Chromatography and other downstream processing equipment, clean-in-place systems, parts washers, autoclaves and utility systems.
• Excellent communications and interpersonal skills are a necessity. These include technical writing, speaking and presentation proficiencies as well as listening, comprehension and cooperation abilities.
• Working knowledge of cGMP guidelines for pharmaceutical processing. Understanding of practical application and importance of cGMP requirements as related to Change and Revision Control, Validation, Quality Assurance, and Regulatory Filings
• A demonstrated record of achievement in small project execution, cross-functional team contribution and equipment troubleshooting.
• Represent the Engineering & Validation department on teams requiring relevant primary experience (Process, Automation, Utilities or Validation)
Prioritization and self-directed coordination of engineering and maintenance activities.
• Proactively interact with related groups including all Biopharm Process Development Groups, siteengineering and maintenance, Quality Assurance, Document Control, and Validation
• Experience and knowledge in validation work processes required. Experience in executing and documenting lOQ and PQ protocols required for validated equipment.
• PE license or EIT is preferred. Masters in engineering or MBA is preferred.
Details:
• The Process and Utility Engineer in the Engineering & Validation group facilitates interaction within and between Biopharm R&D departments and GSK’s site engineering. The R&D departments include Process Development, Clinical Active Supply (manufacturing), QA, QCC, Validation and Document Control.
• A key focus for the Process and Utility Engineer will be to supply equipment engineering support to the process development groups that work on Microbial and Mammalian Cell Culture processes and their associated analytical methods.. The engineer will 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.. .
• The Process and Utility Engineer will be responsible for establishing and managing maintenance and calibration schedules for R&D equipment and instrumentation.
• The Process and Utility Engineer will 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.
• The Process and Utility Engineer will identify and report on equipment and utility improvements, operational efficiency and/or cost saving opportunities within the Biopharm R&D community. From these reports the engineer will prepare and submit Capital Project Proposals.
• The Process and Utility Engineer may also 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.
• The Process/Project Engineer will develop and/or improve equipment and procedure documentation including Functional Requirement Specifications, Standard Operating Procedures and engineering documentation maintenance procedures among others.
GlaxoSmithKline is an equal opportunity employer, M/F/D/V - and we are proudly committed to diversity in our workforce.
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| | Company | | GSK | Job Code | | State or Province | | Pennsylvania | | |
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