A leading engineering services firm in Kentucky is seeking a dedicated CQV Specialist to support commissioning, qualification, and validation activities for packaging equipment in a biotechnology manufacturing environment. The ideal candidate will have a Bachelor's degree in Engineering or Life Sciences and a minimum of 5 years of experience in CQV or validation within pharmaceutical settings. This role ensures compliance with cGMP and FDA regulations while maintaining the highest ethical standards and documentation accuracy.
Qualifications
Minimum of 5 years of experience in CQV, validation, or commissioning.
Experience in pharmaceutical or biotechnology environments.
Familiarity with packaging line equipment preferred.
Responsibilities
Support CQV activities for packaging equipment and systems.
Develop and execute validation documentation protocols.
Verify readiness of packaging equipment installation.
Coordinate with teams for proper startup of packaging lines.
Maintain accurate documentation for validated systems.
Skills
CQV expertise
Strong technical writing
Cross-functional collaboration
Knowledge of cGMP regulations
Validation documentation experience
Education
Bachelor’s degree in Engineering or Life Sciences
Job description
A leading engineering services firm in Kentucky is seeking a dedicated CQV Specialist to support commissioning, qualification, and validation activities for packaging equipment in a biotechnology manufacturing environment. The ideal candidate will have a Bachelor's degree in Engineering or Life Sciences and a minimum of 5 years of experience in CQV or validation within pharmaceutical settings. This role ensures compliance with cGMP and FDA regulations while maintaining the highest ethical standards and documentation accuracy.