KH
Equipment CQV Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
2 weeks ago
- GMP
2 weeks ago
Not enough detail in this posting to match
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.
- 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.
Equipment CQV Engineer · Katalyst Healthcares & Life Sciences