The Senior Validation Engineer will have the following responsibilities:
This individual will provide Quality Assurance support for validation activities associated with equipment, processes & facilities to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, corporate policies, and site Standard Operating Procedures (SOP). Work closely with the various departments in the design and development of validation protocols to ensure the purpose, testing and intended outcomes are defined and are in compliance with the Master Validation Plan and applicable GMP and regulatory requirements.
- Ability to read/interpret validation and engineering documents (protocols and reports).
- Ability to interpret and relate Validation standards for implementation and review of functional areas.
- Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements.
- Review Change Controls, Incidents, Investigations, CAPAs, SOPs.
The ideal candidate will have the following skill set:
- Bachelor's degree (B.A. / B.S.) in a scientific or engineering discipline.
- 3 years QA validation experience in the pharmaceutical industry in a cGMP setting.
- A collaborative spirit and willingness to learn
Compensation:
Competitive base salary + Full Medical Benefits + Relocation for the right candidate
