Vacancy expired!
- Responsible for ownership of all lifecycle deliverables in the qualification of equipment and multi-user computerized systems
- Planning, preparation and execution of equipment and process validation protocols and reports in support of the site's validation program; as well as cleaning validation of clean-in-place systems, packaging equipment and production facilities
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment
- Supervises vendors for qualification functions
- 2+ years experience in FDA-regulated industry performing IQ/OQ/PQ functions or writing protocols/URS
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
- Experience with Process or Packaging Validation (Cleaning validation is a plus, but not necessary)
- Working knowledge of ISPE guidance and 21 CFR Part 11 compliance
- Experience with Technical Writing - validate protocols and related documents
- BS in Engineering/Science or equivalent
- $40-$43/hr
- Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO
Vacancy expired!