Must Haves:

• 2 years Validating Manufacturing equipment and Validating QC equipment

Pharmaceutical industry experience is a must-have. (Cell therapy manufacturing preferred). Please do not submit candidates who have not recently worked for Pharmaceutical manufacturing companies.

The client will not consider consultants who have been working on 1-2 year contracts assignment. This is a full-time direct-hire position, so contractor will not be considered. Stable work history is required.

The QA Validation Engineer is responsible for validating and qualifying equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures in support of HCATS Quality Systems. This role is responsible for reviewing, revising and approving qualification and validation protocols and reports (e.g. facilities, processes, and equipment). Collaborates cross-functionally to support required on-going compliance activities. Support continuous improvement activities and fostering of quality mindset.

This position will report to the Associate Manager, Quality Compliance. 

Essential Functions and Responsibilities

• Supporting validation activities in a cGMP regulated manufacturing environment: review and approve executed qualification and validation documents (IQ, OQ, PQ), for facilities, processes, and equipment.


• Troubleshooting of process issues, process characterization and root cause investigations.


• Resolving deviations observed during execution of qualification and validation activities.


• Approve final reports summarizing the results of executed Validation, Qualification studies.


• Prepare and issue change controls, CAPAs, and investigation reports after validation activities.


• Participate in planning committee meetings to plan qualification and validation activities with key stakeholders ensuring quality requirements are enforced (e.g. Validation Production Operators, and Engineering).


• Support all internal and external (e.g. cGMP, client, regulatory agencies) audits.


• Engage in quality system continuous improvement initiatives to enforce the quality culture.

Qualifications

• B.S.  in  Engineering  or related  life  science  Bachelor's Degree is required. Electrical  Engineering background preferred but not required.


• Minimum  of  five  years  of  experience  in  the  pharmaceutical  or  related  industry; equivalent combination of education and experience acceptable.


• Familiar with FDA, ISO, and other regulatory agency guidelines.


• Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.