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Job Description

Our pharmaceutical client is seeking a CQV Validation Engineer to join their team in Andover, MA. This role will focus on the commissioning, qualification, and validation (CQV) of 20 freezers and chambers to ensure they meet all quality and regulatory standards. The ideal candidate will work closely with cross-functional teams to develop and execute comprehensive validation protocols across these critical systems.

Key Responsibilities

o Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for the assigned freezers and environmental chambers.

o Oversee and manage the complete validation lifecycle to ensure equipment performs as specified.

o Prepare, review, and maintain detailed validation documentation in compliance with cGMP, FDA, and other applicable regulatory guidelines.

o Ensure all validation reports are thorough, accurate, and audit ready.

o Work closely with Quality Assurance, Engineering, and Operations teams to integrate validation activities into ongoing projects.

o Coordinate with external vendors and contractors as necessary to facilitate validation tasks and equipment modifications.

o Identify, document, and resolve any issues encountered during the validation process.

o Implement process improvements based on testing outcomes and industry best practices.

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

Bachelors degree in Engineering, Life Sciences, or a related field.

Proven experience in CQV activities within the pharmaceutical or life sciences industry.

Detailed knowledge of validation protocols (IQ/OQ/PQ) and regulatory requirements (e.g., cGMP, FDA guidelines).

Strong analytical, troubleshooting, and project management skills.

Excellent written and verbal communication skills.

Experience with LLAB software 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 [email protected].