Validation Engineering
4 weeks ago
A services company in Lawrence Kansas is currently seeking a new Validation Engineer for a great opportunity with their team. In this role, the Validation Engineer will be responsible for supporting validation engineering group by generating validation protocols, executing protocols and leading the review/approval process in a pharmaceutical environment.
Responsibilities:
The Validation Engineer will:
- Be the lead on pharmaceutical validation efforts associated with newly installed or modified equipment, facilities or utilities systems, or revalidation of existing equipment
- Work with change owners to define changes to validated systems and the testing required per plant operating procedures
- Coordinate validation activities with plant operations and other plant supporting functions such as quality testing and instrument calibrations
- Write and review validation protocols, including installation, operational and performance qualifications, using plant procedures and industry standards
- Lead execution of validation protocols and ensure proper documentation of results (good documentation practices)
- Analyze results of testing and implement proper validation activities if results do not meet requirements (i.e., discrepancy generation)
- Perform full, detailed review of validation packages prior to submission for approval
- Write and review validation summary reports
- Maintain schedules of ongoing validation activities
- 2+ years experience in Equipment / Software Validation in a Pharmaceutical environment
- Bachelor's degree in Science or Engineering
- Comfortable and familiar with gowning requirements for cleanroom environment (i.e., some testing and observation to be done in a cleanroom).
- Familiar with cGMPs, FDA and pharmaceutical guidelines
- Familiar with the validation life cycle, and integrated commissioning & qualification approach.
- Great interpersonal skills
- Excellent communication skills (written and verbal)
- Strong attention to detail
- Highly organized
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