Job Information
Insight Global Senior Validation Engineer in Parsippany, New Jersey
Job Description
Seeking a mid- to senior-level Validation Engineer to support commissioning and qualification activities within a pharmaceutical manufacturing environment. The role will be responsible for generating and executing IQ, OQ, and PQ protocols for equipment, utilities, and packaging systems, ensuring compliance with cGMP and regulatory expectations. The candidate should be comfortable working both independently and collaboratively, with the ability to lead validation activities and drive projects to completion.
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.To 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
· Author and execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
· Support qualification of process equipment, packaging lines, laboratory equipment, utilities, and facility systems.
· Perform temperature mapping studies for controlled temperature equipment and storage areas.
· Support cleanroom and room qualification activities.
· Execute or support media fills (aseptic process simulations) and smoke studies.
· Support Environmental Monitoring (EM) studies.
· Investigate and document deviations encountered during qualification activities.
· Prepare validation documentation and summary reports.
Work cross-functionally with internal teams (i.e., Engineering, Quality, Manufacturing, Supply Chain, and Validation) to support qualification activities and ensure project timelines are met.