GxP Validation Engineer
Insight Global
Job Description
One of our large clients in the pharmaceutical industry in Spring House, PA is seeking a highly skilled and detail-oriented GxP Validation Engineer to support validation activities for CAR T-cell therapy manufacturing equipment and systems. This role is critical to ensuring compliance with GMP standards and regulatory requirements across a range of manufacturing and laboratory technologies.
Key Responsibilities:
• Execute GxP validation activities for CAR T manufacturing equipment, including specialized systems and cell processing instruments, such as Prodigy.
• Develop and author validation documentation including protocols, connection diagrams, and final reports.
• Validate temperature control units such as refrigerators and freezers.
• Collaborate with cross-functional teams to ensure validation deliverables meet project timelines and regulatory standards.
• Support audits and inspections by providing validation documentation and subject matter expertise.
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
• Minimum 3-5 years of experience in GxP validation within a GMP-regulated environment.
• Strong understanding of GMP compliance and validation lifecycle.
• Familiarity with temperature-controlled equipment validation. • Knowledge of automation systems and Computer System Validation (CSV).
• Proven experience with CAR T manufacturing equipment.
• Hands-on experience with MeS and DCS validation. null
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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
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