Equipment Validation Engineer

A pharmaceutical company in the RTP, NC area is looking for an Equipment Validation Engineer to join their growing team. This person will be responsible for:
Providing support for autoclaves, isolators, parts washers, decontamination area, etc
Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility
Author/review executed equipment qualification protocols and summary report
Drive planning activities
Assist with the execution of equipment qualification protocols
Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures; Collect and analyze data to make data driven recommendations/decisions
Production oversight during validation events
Provide qualification support for systems as assigned.
Work on other projects and tasks as needed to support the site.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience

Bachelor's degree in Engineering or related field
3+ years of validation experience in a cGMP environment, supporting equipment qualification and facilities commissioning activities
Knowledge of validation software systems: Kneat

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.