Commissioning, Qualification, and Validation (CQV) Engineer

We are seeking a highly skilled and motivated Commissioning, Qualification, and Validation (CQV) Engineer to join our team for a pharmaceutical manufacturing facility build project. The CQV Engineer will play a crucial role in ensuring that our facility and equipment meet all regulatory and quality standards, are properly installed, and are validated to perform their intended functions.

Key Responsibilities

Commissioning:
- Oversee the installation and startup of new equipment and systems, ensuring they meet the manufacturer’s specifications and project requirements.
- Develop and execute commissioning plans, including protocols for system checks, equipment testing, and performance validation.
- Coordinate with engineering, construction, and operations teams to ensure smooth project execution and address any issues that arise during commissioning.
Qualification:
- Lead and manage the Qualification process for equipment, systems, and facilities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
- Develop and review Qualification plans, protocols, and reports to ensure compliance with regulatory requirements and company standards.
- Analyze data from qualification activities to verify that systems and equipment operate consistently and meet all intended use requirements.
Validation:
- Develop and implement validation strategies for manufacturing processes, including process validation and cleaning validation.
- Create and execute validation plans and protocols, ensuring that all validation activities are documented and compliant with FDA, EMA, and other regulatory bodies.
- Review and approve validation documentation, including validation reports and risk assessments.
Compliance and Documentation:
- Ensure all CQV activities comply with current Good Manufacturing Practices (cGMP), FDA regulations, and other relevant standards.
- Maintain accurate and comprehensive documentation of commissioning, qualification, and validation activities, including protocols, reports, and change controls.
- Provide support during regulatory inspections and audits, addressing any findings or observations related to CQV activities.
Continuous Improvement:
- Identify opportunities for process improvements and work with cross-functional teams to implement enhancements.
- Stay current with industry trends, regulatory changes, and new technologies relevant to CQV activities.

Requirements

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field.
Minimum of 10 years of experience in CQV engineering within the pharmaceutical or biotech industry.
In-depth knowledge of cGMP regulations, FDA guidelines, and industry standards related to CQV activities.
Experience with equipment and process validation, commissioning, and qualification activities.
Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.
Excellent communication skills, both written and verbal, with the ability to interact effectively with various stakeholders.
Proficiency in using CQV software and tools is a plus.

Preferred Qualifications

Certification in CQV or related fields (e.g., ASQ Certified Quality Engineer).
Experience with large-scale pharmaceutical manufacturing facility build projects.
Knowledge of automated systems and control systems validation.

Soft Skills

Cross-Cultural Communication
Adaptability and Flexibility
Team Collaboration and Interdisciplinary Skills
Problem-Solving and Critical Thinking
Emotional Intelligence
Time Management and Prioritization
Ethical Awareness and Sustainability Focus
Conflict Management
Stakeholder Engagement
Continuous Learning Mindset

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General Information

Vacancy: 016

Location: Europe

Contract type: 1 year rolling contract, consulting contract.

Project duration: 1-2 years.

How to Apply?

If you’re interested in this role, we’re looking forward to hear from you! Kindly apply via the JTR Consultancy Services website with your CV in Word Document version – one of our Business Development Managers will be in touch with you shortly.