Computer Systems Validation (CSV) Engineer

The Computer Systems Validation (CSV) Engineer will play a critical role in ensuring that computerized systems within the pharmaceutical manufacturing facility meet regulatory compliance and industry standards throughout the project lifecycle. The position will support the validation of manufacturing, laboratory, and facility-related systems as part of a facility build project, ensuring the integrity, quality, and compliance of systems with global regulations such as FDA 21 CFR Part 11, GAMP 5, and EU GMP Annex 11. The CSV Engineer will work closely with cross-functional teams, including IT, Quality Assurance, Engineering, and Operations.

Key Responsibilities

CSV Lifecycle Management:
- Develop, implement, and manage the Computer Systems Validation (CSV) plan in line with project requirements.
- Lead the validation process for GxP computerized systems, including laboratory information management systems (LIMS), manufacturing execution systems (MES), enterprise
- resource planning (ERP) systems, building management systems (BMS), and other IT infrastructure.
- Oversee the creation, execution, and documentation of validation deliverables, including User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments (RA), Design Specifications (DS), IQ/OQ/PQ Protocols, and Validation Summary Reports (VSR).
Regulatory Compliance:
- Ensure compliance of computerized systems with global regulatory standards including FDA 21 CFR Part 11, GAMP 5, EU GMP Annex 11, and other applicable guidelines.
- Identify and mitigate risks associated with computer systems, ensuring data integrity, system security, and adherence to good documentation practices (GDP).
- Support regulatory audits and inspections by providing validation documents and demonstrating compliance.
Project Support:
- Participate in project planning, scheduling, and coordination of CSV-related activities, working alongside engineering and construction teams during the facility build.
- Review vendor documentation, including system design specifications, and ensure systems are validated and tested in alignment with project timelines.
- Coordinate with vendors and contractors for the qualification and validation of software and hardware components of systems.
Document Management:
- Develop and manage validation documentation throughout the system’s lifecycle, including traceability matrices, test scripts, and deviation reports.
- Perform system testing (IQ/OQ/PQ) to verify that systems meet their intended use and design requirements.
- Maintain records of system upgrades, change control, and periodic reviews of systems after the initial validation.
Training and Support:
- Provide training to key stakeholders, including IT staff, operators, and quality assurance teams, on the validated systems.
- Act as the subject matter expert (SME) for all computer system-related validation issues, troubleshooting system issues, and offering guidance on validation best practices.
Continuous Improvement:
- Identify opportunities for improving validation practices, processes, and systems to align with the latest industry trends and technologies.
- Work proactively with Quality and Engineering teams to implement improvements in systems that drive efficiencies in the facility

Requirements

Qualifications

Bachelor’s degree in Computer Science, Engineering, Information Technology, or related field. Master’s degree preferred.
Minimum 10 years of experience in computer systems validation, preferably within the pharmaceutical, biotechnology, or medical device industry.
Experience in validating systems within a facility build/commissioning project is highly desirable.
Hands-on experience with regulatory compliance standards such as GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11.
Proficient in developing validation plans, protocols, and technical documentation.
Strong understanding of pharmaceutical manufacturing processes and automated systems.
Familiarity with laboratory systems (LIMS), manufacturing execution systems (MES), enterprise systems (ERP), and building management systems (BMS).
Knowledge of system lifecycle management, IT infrastructure, and cybersecurity principles.

Preferred Qualifications:

Certification in Computer Systems Validation or related fields.
Familiarity with project management methodologies (e.g., Agile, Waterfall).
Experience with cloud-based systems or emerging technologies in pharmaceutical manufacturing.

Key Competencies:

In-depth knowledge of the regulatory environment in the pharmaceutical industry.
Ability to manage multiple validation projects and deadlines.
Team player with strong collaboration skills.
Ability to troubleshoot complex issues in computerized systems.

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: 008

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.