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Process Engineer
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Process Engineer : GlaxoSmithKline
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| Job Number |
55612 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Upper Merion
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
10/8/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Engineering |
| Required Degree |
Bachelors Degree |
| Relocation |
Not Required |
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| Description |
Basic Qualification
• 5 to 10 years pharmaceutical engineering experience and exposure to biopharmaceutical processing activities is required.
• BS degree in Biochemical Engineering, Chemical, Mechanical, Electrical Engineering is required. The successful candidate will have:
• Broad based knowledge of Biopharmaceutical and Biotechnology processing methods
• 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 cGMPs and NIH 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 activities.
• Proactively interact with related groups including manufacturing, maintenance, Quality Assurance, Document Control, Validation and GSK Site Engineering.
• Experience and knowledge in validation work processes required. Experience in executing and documenting lOQ and PQ protocols required.
Details
• The Utility and Process Engineer in the Engineering & Validation group facilitates interaction within and between BiopharmR&D departments and GSK’s site engineering. The R&D departments include Process Development, Clinical Active Supply (manufacturing), Engineering, QA, QCC, Validation and Document Control.
•A key focus for the Utility and Process Engineer will be on the Microbial and Mammalian Cell Culture aspects of the Pilot Plant facility operations. The engineer will work closely with the manufacturing group to understand procedures and process steps from vial thaw and seed scale-up to small- scale production bioreactors. Primary manufacturing methods concentrate on CHO cell expression systems for the production of monoclonal antibodies and other recombinant proteins. The Utility and Process Engineer will identify and report on process improvement, operational efficiency and/or cost saving opportunities within the BiopharmR&D community. From these reports the engineer will prepare and submit Capital Project Proposals.
•The Utility and Process 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 The Utility and Process Engineer will also concentrate on utilizing the multi-product capabilities of the Pilot Plant.
•The Utility and Process Engineer will provide support to the group Project Managers on maintenance, upgrade and capital project activities that may range from control system augmentation to process equipment commissioning. These 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/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. |
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| Requirements |
Preferred Qualification
• PE or EIT is preferred. Masters in engineering or MBA is preferred. |
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| Contact Info |
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