Equipment and Computer System Validation Engineer I


Job ID 18-00084

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Essential Duties:
1. Has the ability to analyze a system and its intended use, and determine IQ/OQ/PQ testing needed, sometimes where there are no formal specifications, based on Users intended use and knowledge of cGMP/GxP/Part 11 industry expectations.
2. Extensive experience writing validation protocols, reports, and validation deviations for complex systems is a must. (strong writing and verbal communication skills.)
3. Write and execute Equipment Qualification and Computer System Validation (CSV) protocols for lab and manufacturing equipment/instruments supporting a sterile pharmaceutical formulation, fill, and finish multi-product facility.
4. Use troubleshooting and critical thinking skills to investigate, remediate, and resolve technical obstacles and deviations encountered.
5. Once oriented and aligned on strategy disseminated from the Validation Manager, progress IQ/OQ/PQ deliverables to closure with a certain level of independence.



Qualifications

Preferred Qualifications:
1. Proficient in both Equipment Qualification and Computer System Validation (CSV) with at least 5-9 years validation experience working in these areas within Pharma, Med Device, and/or Biopharma industry.
2. Four year college degree, preferably in Science (e.g. Biology, Chemistry, Pharmaceutical Science, etc.) or Engineering.
3. Strong writing and verbal communication skills are a must.