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Job Description

Insight Global is hiring a Validation Engineer in Massachusetts to support their client. This position is based on-site as the engineer will be required to interface with manufacturing equipment, medical device products, and cross-functional partners. The daily tasks in scope of this role include but are not limited to the following:

Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e. Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing

Supporting the development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ)

Supporting the development and execution of process validations (OQ/PQ/PV)

Developing, writing, and reviewing various validation deliverables, i.e. CSV-E, Engineering Studies, etc.

Partnering with cross functional partners to ensure sound validation strategy and smooth transitions to production go-live

Ensuring adequate documentation where necessary within the Quality System In order to successfully deliver on the above the incumbent will apply comprehensive and diverse knowledge of Engineering principles and practices as well as problem solving, risk management skills, and communication skills.

This candidate will also be responsible for equipment design, implementation, and validation

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 [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

Validation experience bringing in equipment.

Bring in equipment

3+ years of experience validation

Med Device or regulated

IQ OQ PQ Preferably J&J before

CMM validation

Foundry