CQV Equipment Engineer GMP Validation

Katalyst-Healthcares-

Job Summary
We are seeking an experienced Equipment CQV Engineer to support an GMP equipment commissioning and qualification program at a biopharmaceutical manufacturing facility in Massachusetts. The engineer will be responsible for hands-on execution of equipment commissioning, qualification, and validation activities across manufacturing, laboratory, and facility support equipment.

Roles and Responsibilities

Execute equipment commissioning and qualification activities in accordance with approved GMP procedures and qualification protocols.
Review and execute IQ, OQ, and other equipment qualification protocols.
Perform hands-on testing and verification of manufacturing, laboratory, and support equipment.
Document test results, observations, and qualification activities accurately and in compliance with Good Documentation Practices (GDP).
Identify, investigate, and support resolution of discrepancies, deviations, and protocol execution issues.
Prepare and review qualification documentation, including test records, equipment documentation, and supporting evidence.
Work closely with Engineering, Validation, Manufacturing, Quality Assurance, and equipment vendors to ensure equipment readiness.
Support equipment turnover and readiness activities for manufacturing and engineering operations.
Ensure qualification activities are performed in accordance with applicable GMP, SOP, and site validation requirements.
Manage multiple equipment qualification packages and complete assigned activities within project timelines.
Participate in troubleshooting and resolution of equipment-related qualification issues.
Support change controls, deviations, CAPAs, and other quality-system activities as required.
Maintain clear and complete qualification records and ensure documentation is audit-ready.
Communicate qualification status, execution issues, and project risks to relevant stakeholders.

Education & Experience

Bachelor's degree in engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related technical discipline.
Equivalent combination of education and relevant industry experience may be considered.

Approximately 5–10 years of experience in CQV, equipment validation, equipment qualification, commissioning, or a related field.
Strong hands-on experience executing IQ/OQ and other equipment qualification protocols.
Experience working in GMP-regulated pharmaceutical, biotechnology, biopharmaceutical, cell therapy, or life sciences manufacturing environment.
Experience qualifying manufacturing, laboratory, utility, or other GMP equipment.
Demonstrated ability to review protocols, execute testing, document results, and resolve discrepancies or deviations.

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Vacancy posted 3 days ago

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