CQV Engineer
CQV Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description CQV LEAD POSITION
POSITION:
We are seeking an experienced and detailoriented CQV Lead to oversee and execute commissioning qualification and validation activities for process equipment and laboratory systems within a GMPregulated pharmaceutical environment. This role is critical in ensuring that all equipment and lab systems are designed installed tested and maintained according to regulatory requirements and internal quality standards.
RESPONSIBILITIES:
Lead CQV efforts for new and existing process equipment and lab instruments/systems ensuring compliance with cGMP FDA EMA and ICH guidelines.
Develop and review CQV documentation including URS DQ IQ OQ PQ protocols and reports.
Coordinate and oversee commissioning activities including FAT and SAT and ensure proper transition to qualification.
Perform risk assessments (e.g. impact assessments component criticality analysis) to define qualification scope.
Collaborate with Engineering Quality Assurance Manufacturing and Validation teams to ensure project alignment.
Support lab system validation including analytical instruments data integrity and computerized system validation (CSV) where applicable.
Troubleshoot and resolve CQVrelated issues and deviations.
Participate in regulatory audits and inspections; provide SMElevel support on equipment and lab validation topics.
Maintain uptodate knowledge of validation regulations industry best practices and technological advancements.
QUALIFICATIONS:
Bachelors degree in Engineering Life Sciences or related technical discipline (Masters preferred).
5 years of experience in CQV within the pharmaceutical/biotech industry with a strong focus on process equipment and lab systems.
Solid understanding of GMP regulations GAMP 5 21 CFR Part 11 and other relevant guidelines.
Proven experience in writing and executing qualification protocols.
Familiarity with analytical lab equipment (HPLCs GCs incubators etc. and CSV principles.
Excellent project management organizational and communication skills.
Ability to work independently and manage multiple priorities in a fastpaced environment.
PREFERRED EXPERIENCE:
Experience with clean utilities (e.g. WFI clean steam HVAC) and process support systems.
Knowledge of MES LIMS or other laboratory management systems.
Previous experience in greenfield or brownfield facility startup projects.
Employment Type
Full Time
