Validation Engineer

We are seeking a skilled and detail-oriented Validation Engineer to join our team for a critical pharmaceutical manufacturing facility build project. The ideal candidate will have experience in validating processes, equipment, and systems in the pharmaceutical or biotech industry. You will play a crucial role in ensuring that all aspects of the facility meet regulatory requirements and are compliant with Good Manufacturing Practices (GMP).

Key Responsibilities

Validation Planning:
- Develop and implement validation strategies and plans for equipment, systems, and processes.
- Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs).
Equipment and Systems Validation:
- Conduct installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for new and existing equipment.
- Validate computerized systems and software, ensuring compliance with 21 CFR Part 11 and other regulatory standards.
Process Validation:
- Develop and execute process validation studies, including validation of manufacturing processes, cleaning processes, and analytical methods.
- Ensure that processes consistently produce products meeting quality standards and specifications.
Regulatory Compliance:
- Ensure that all validation activities comply with FDA, EMA, and other relevant regulatory requirements.
- Maintain up-to-date knowledge of industry regulations, standards, and best practices.
Documentation and Reporting:
- Prepare detailed validation documentation and reports, including validation plans, protocols, and final reports.
- Document and investigate deviations, implement corrective and preventive actions (CAPAs), and ensure timely resolution.
Cross-Functional Collaboration:
- Work closely with engineering, quality assurance, production, and other teams to support the successful validation of equipment and processes.
- Provide validation expertise and guidance throughout the project lifecycle.
Training and Support:
- Train and mentor team members on validation practices, procedures, and regulatory requirements.
- Provide technical support and guidance during the facility build and commissioning phases.

Requirements

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
Minimum of 10 years of experience in validation within the pharmaceutical or biotech industry.
Strong knowledge of GMP, FDA regulations, and other relevant industry standards.
Experience with validation of equipment, processes, and computerized systems.
Proficiency in developing and reviewing validation documentation and protocols.
Excellent problem-solving skills and attention to detail.
Strong communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.

Preferred Qualifications

Certification in Validation (e.g., Certified Quality Engineer (CQE), Certified Validation Professional (CVP)) is a plus.
Experience with project management and facility build projects in the pharmaceutical industry.

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: 015

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.