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Validation Engineer I
Perrigo Company plcValidation Engineer responsible for preparing and reviewing validation plans at Perrigo in Allegan, MI. Ensure conformance with regulatory requirements and assess deviations for corrective actions.
About the role
Key responsibilities & impact- Prepare and review plans, protocols, reports, and studies associated with validation activities
- Ensure that validation events occur in conformance with approved procedures and regulatory requirements
- Coordinate the timing of validation events
- Assess deviations and recommend corrective actions as necessary
- Perform validation periodic reviews and revise/review master plans and standard operating procedures
- Review technical documents to ensure that validation acceptance criteria are consistent with product and process specifications
Requirements
What you’ll need- Bachelor's degree in Engineering, Chemistry, Pharmacy or a closely allied field
- One year of pharmaceutical industry experience required
- High level of analytical skills with proven problem-solving ability
- Experience in the interpretation and application of FDA requirements and cGMP
- Ability to write technical documents relating to applications and systems of medium complexity
- Demonstrated ability to organize multiple tasks and changing priorities to meet project deadlines
- Excellent oral and written communication skills
- Basic understanding of statistics preferred
- Computer literacy is required.
Benefits
Comp & perks- Competitive compensation
- Benefits tailored to supporting you and your family
- Career development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
validation activitiestechnical document reviewanalytical skillsproblem-solvingFDA requirementscGMPstatisticswriting technical documentsmaster plansstandard operating procedures
Soft Skills
organizational skillsability to manage multiple tasksability to adapt to changing prioritiesoral communication skillswritten communication skills