CQV Project Manager

The CQV Manager is responsible for overseeing the commissioning, qualification, and validation activities for pharmaceutical facilities, utilities, equipment, and processes in compliance with client's quality standards, FDA regulations, and other applicable industry guidelines. This role ensures that systems and processes are properly tested and validated to meet regulatory and operational requirements, supporting the delivery of high-quality products to patients.

Key Responsibilities:

Commissioning & Qualification:

Lead the development and execution of CQV activities for manufacturing facilities, utilities, equipment, and processes.

Ensure all systems meet design specifications, operational requirements, and regulatory standards.

Oversee the preparation, review, and approval of CQV documentation, including protocols, reports, and risk assessments.

Validation:

Manage and execute process, cleaning, and equipment validation activities.

Identify and resolve issues during validation to minimize risks and ensure compliance.

Collaborate with cross-functional teams to ensure alignment on validation strategies and timelines.

Compliance:

Ensure adherence to Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and other regulatory requirements.

Stay updated on regulatory changes and implement necessary adjustments to CQV processes.

Provide support during audits and inspections, including FDA and other regulatory bodies.

Project Management:

Lead CQV activities in alignment with project timelines, budgets, and objectives.

Coordinate with internal teams and external vendors/contractors to ensure smooth execution of CQV deliverables.

Identify risks and implement mitigation strategies to ensure successful project outcomes.

Leadership and Training:

Mentor and guide CQV team members to enhance their skills and knowledge.

Conduct training sessions on CQV processes and regulatory requirements.

Foster a culture of continuous improvement and collaboration within the team.

Required Qualifications:

Bachelor’s degree in Engineering, Life Sciences, or a related field.

Minimum of 5-8 years of experience in CQV roles within the pharmaceutical or biotech industry.

Strong knowledge of FDA regulations, GMP, GEP, and industry guidelines (e.g., ISPE, ICH).

Proven experience with equipment qualification, process validation, and facility commissioning.

Excellent project management skills, with the ability to manage multiple priorities and stakeholders.

Strong analytical, problem-solving, and communication skills.

Familiarity with electronic validation systems and documentation tools.