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Apply online for the
Validation Manager
position and advance your career in the
Pharmaceutical industry today.
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Validation Manager : GlaxoSmithKline
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| Job Number |
54430 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Marietta
Pennsylvania
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
6/17/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Quality-Assurance |
| Required Degree |
Bachelors Degree |
| Relocation |
Required |
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| Description |
Basic Qualification
If you believe you can be successful in a challenging manufacturing environment with a global organization and possess all of the following minimum qualifications, we encourage you to apply immediately:
• BS/BA required. A degree in biology, chemical engineering, life sciences preferred.
• Prior experience in pharmaceutical industry (5-8 years minimum), preferably in Vaccines.
• Minimum of three years management or supervisory experience.
• Aseptic Process Equipment knowledge.
• Familiarity with Good Manufacturing Practices and NIH Guidelines for large scale recombinant biological processing.
• Prior experience interfacing with regulatory agencies.
• Project Management Experience.
• Demonstrated leadership with ability to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
• Computer skills in Microsoft Office applications and the ability to quickly and easily learn new applications.
GSK Biologicals, N.A. is committed to being the Best Place for the Best People to do their Best Work. This is accomplished through our Total Reward competitive compensation package, our employee performance and development planning and our diverse, challenging, and innovative work environment.
Details
GSK Biologicals, N.A. with our global quest to improve the quality of human life by enabling people to do more, feel better and live longer, is seeking a Validation Manager for our vaccine production facility in Marietta, PA.
The Validation Manager will be responsible for leading and motivating the Marietta site validation team, including GSK and contract employees, responsible for providing technical expertise in defining, developing, executing and supporting all start-up and continuous validation activities on site to include automated computer systems, aseptic facility controls, manufacturing equipment, and supporting utilities. Day to day job duties include:
• Define, develop, analyze and approve specific technical requirements or strategies for projects and process equipment to include an adjuvant manufacturing skid; aseptic formulation, filling, and lyophilization equipment; two labeling and packaging lines and cold chain storage.
• Provide technical support for utility systems including: purified water, WFI, compressed air systems clean steam systems, nitrogen systems.
• Establish and implement technical standards (technical specifications) in compliance with GMP regulatory and GSK Biological requirements.
• Develop and review standard and specific qualifications (IQ/OQ/PQ and PV protocols) for related equipment and devices in order to comply with GMP regulatory and GSK Biological requirements.
• Insure compliance and readiness for inspection and provide adequate support to inspected departments. Provide technical and commercial input on procedures for supplier’s selection.
GSK Biologicals in Marietta is a beautiful community located along the Susquehanna River in Lancaster County, Pennsylvania. Our employees enjoy the proximity to larger metropolitan areas and benefit from more affordable housing, excellent school systems, and access to a multitude of recreational activities and the more relaxed lifestyle that the area has to offer. |
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| Requirements |
Preferred Qualification
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| Contact Info |
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Apply online at company website |
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