What are the responsibilities and job description for the CQV Engineer position at TekOne IT Services Pvt. Ltd.?
Provide CQV services to clients in the Life Sciences Industry, including commissioning, qualification, validation, and consulting as defined in project scopes.
Execute validation activities that drive overall quality and compliance at client facilities, adhering to client standards and regulatory requirements.
Participate in project teams executing various commissioning and validation projects under the guidance of a project manager or validation lead, providing routine progress updates.
Generate protocols for commissioning and qualification, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and final reports.
Conduct commissioning, qualification, and validation testing of facilities, utilities, manufacturing processes, and instrumentation.
Identify, investigate, and resolve deviations during commissioning and qualification testing.
Create essential documentation such as master plans, design qualifications, user and functional requirements.
Collaborate with clients to identify CQV needs, working towards solutions that meet schedule, cost, and quality expectations.
Review equipment specifications, manuals, and develop an understanding of equipment functionality to ensure testing meets intended use requirements.
Analyze and review turnover packages and spare parts lists to ensure compliance with user and functional requirements.
Review and validate P&IDs and drawings for accuracy.
Author and execute DQ, FAT, SAT, commissioning, IQ, OQ, PQ, and Process Validation (PV) documents, develop Standard Operating Procedures (SOPs), create final reports, and author validation and quality procedures and guidelines.
Apply knowledge of GMP, GCP, GLP, GAMP, and CFR 21 Part 11 guidelines to ensure compliance in the qualification of systems and validation of processes.
Demonstrate self-direction and the ability to work independently or as part of a team.
Utilize strong analytical, organizational, time management, and problem-solving skills to meet project objectives.
Qualifications
Bachelor’s degree in Electrical, Mechanical, Chemical, Biochemical Engineering, Biological Sciences, or a related field.
Minimum of 7 years of relevant industry experience in CQV projects within the Life Sciences and/or pharmaceutical industry.
Solid understanding of cGMP manufacturing and regulatory requirements for the Life Sciences sector.
Experience in supporting commissioning and qualification projects.
Knowledge of GMP production facility utilities, including Water for Injection (WFI), Cleanroom Environments (HVAC), Clean Steam, and process gases.
Familiarity with manufacturing and utility systems, facility systems, and equipment qualification processes.
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a CQV Engineer?
Sign up to receive alerts about other jobs on the CQV Engineer career path by checking the boxes next to the positions that interest you.
