o Knowledgeable of current standards of computer validation including:
- Bachelor's degree in Engineering or Life Sciences.
- 3-7 years of relevant validation experience. A minimum of 2 years relevant experience in the bulk biopharmaceutical and/or pharmaceutical industry (biopharmaceutical fermentation or purification experience preferred).
- Thorough knowledge of cGMPs required.
- Technical understanding of the industry and validation practices related to the pharmaceutical industry in one or more of the following:
Electronic experiment templates.
Laboratory equipment / instrumentation.
- Knowledgeable of current standards for utility validation.
- Knowledgeable of current standards of cleaning and sterilization validation.
- Mechanical aptitude and hands-on experience with production and validation equipment.
- Demonstrated ability to work on multiple projects, ability to focus on the important projects, and the flexibility to adapt to changing priorities.
- Demonstrated computer skills and experience using Microsoft Word and Excel, required.
- Strong written and verbal communication skills.
- Must be able to interact well with peers and supervisors/managers in multidisciplinary matrix teams involving scientific, engineering, and operational disciplines.
- Quality and detail oriented.
- Can learn and apply new testing techniques.
AUTHORITY AND RESPONSIBILITIES OF JOB:
THE SPECIFIC DUTIES OF THE ROLE/POSITION:
- This individual will be responsible for increasingly complicated validation projects including writing, scheduling and executing validation protocols, gathering and analyzing data, and writing final validation reports.
- This Validation Engineer position will provide hands on validation support within the BioPharm R&D GMP Operations Organization.
- Develops and executes Validation and Qualification Protocols for mechanical equipment, automated equipment/systems, laboratory equipment/instrumentation, utilities, electronic experiment templates, Enterprise Systems, etc with minimal supervision.
- This individual will play a key role in determining the level of validation required to be in compliance with regulatory requirements.
- This individual will serve as the principal validation member representing Validation on project teams.
- This individual may lead specific validation projects and that would entail responsibility for schedule, budget, and deliverables.
- This individual may provide day-to-day supervision to validation contractors.
- This individual is expected to require minimal supervision.
- This individual will participate in development of requirements and specifications.
- This individual will assist in the development of required quality and validation plans, procedures and practices.
- Remain informed of current FDA and industry standards related to validation.
- Contribute to the development and/or improvement of procedures, practices, and policies related to validation, equipment and processes.
- Monitor the Validation Master Plan to ensure that it complies with appropriate regulatory guidelines and standard practices.
- Interface with staff in Operations, Technical Services, Project Engineering, Quality Control & Compliance, and Quality Assurance to coordinate resources and complete validation activities in a timely manner.
- Lead the effort to gain approval of validation protocols, reports, and procedures.
- Perform validation activities associated with change controls and the Validation Maintenance Program.
- Contribute increasingly in the review of new systems and modifications to existing systems to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control.
You may apply for this position online by selecting the Apply now button.
GlaxoSmithKline is an equal opportunity employer, M/F/D/V - and we are proudly committed to diversity in our workforce.
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GlaxoSmithKline - 24 months ago
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GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...