Engineer II, Validation - Computerised Systems Validation Specialist

TN United Kingdom; Birmingham; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an Engineer II, Validation - Computerised Systems Validation Specialist in Birmingham. The role involves developing documentation, collaborating with teams, and ensuring compliance with regulatory standards. Ideal candidates will have a strong background in CSV and regulatory requirements, along with excellent analytical and communication skills.

Qualifications

• Proven experience in CSV in regulated industry.
• Solid understanding of regulatory requirements.

Responsibilities

• Develop and maintain documentation for qualification activities.
• Collaborate with multi-functional teams for software validation.
• Perform risk assessments and develop mitigation strategies.

Skills

Analytical Skills

Problem-Solving

Communication

Education

Bachelor's degree in Computer Science

Master’s degree

Job description

Job Title: Engineer II, Validation - Computerised Systems Validation Specialist, Birmingham

Client: Thermo Fisher Scientific

Location: Birmingham, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 6e9d0792a540

Job Views: 2

Posted: 14.05.2025

Expiry Date: 28.06.2025

Job Description:

• Develop and maintain documentation, including plans, protocols, and reports for qualification activities (IQ, OQ, PQ).
• Collaborate with multi-functional teams, including manufacturing, IT, Quality Assurance, and Regulatory Affairs, to ensure appropriate validation of software systems.
• Perform risk assessments and develop risk mitigation strategies to ensure compliance and data integrity.
• Provide technical expertise and guidance on CSV to internal customers.
• Stay up to date with industry trends and regulatory requirements related to CSV.
• Participate in internal and external audits, where needed, and assist in addressing any findings.

Preferred Skills/Experience:

The Validation team supports all pillars of validation within the business to drive process improvements across manufacturing. We encourage candidates who thrive in a multi-disciplinary, highly technical environment where personal development and collaboration are keys to success. Sound decision-making skills in time-sensitive and sophisticated situations, with a considered assessment of risk, are crucial. Demonstrated experience of handling numerous projects and priorities is a must.

Qualifications:

• Bachelor's degree in Computer Science, Engineering, or a related field. A Master’s degree is preferred.
• Proven experience in CSV in a regulated industry such as pharmaceuticals, medical devices, or biotechnology.
• Solid understanding of regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Preferred: ISO 13485, FDA Part 820.
• Excellent attention to detail and ability to work independently with minimal direction.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.