Validation Officer

Fresenius Kabi AG; Runcorn; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company in Runcorn is seeking a Validation Officer to join their Aseptic Services team. The role involves planning, executing, and maintaining validation activities, ensuring compliance with cGMP standards. The ideal candidate will have a degree in Engineering/Science or extensive experience in a validation role within the healthcare industry. The position offers a supportive environment and a range of benefits, promoting personal and professional development.

Benefits

Contributory Pension Scheme

Life Insurance

25 days holiday

Healthcare cashback scheme

Free onsite parking

Qualifications

• Minimum of a degree in engineering/science or extensive validation role experience.
• Experience and knowledge of cGMP and regulatory requirements.
• Experience in manufacture of sterile medicinal products.

Responsibilities

• Draft, review, and improve validation documentation.
• Execute validation activities relating to facilities and equipment.
• Investigate root causes of non-conformances.

Skills

cGMP knowledge

Risk assessment

Trend analysis

Education

Degree in Engineering/Science

Tools

Thermal mapping instruments

Small systems (balances, pumps)

Job description

Do you have a degree in Engineering/Science or extensive experience working in a Validation role within the Pharmaceutical/healthcare industry? We are looking for a Validation Officer to join our Aseptic Services team to support with planning, executing and maintaining validation activities. The role is 37.5 hours per week Monday‑Friday, 7.5 hours between the hours of 8am - 6pm and it will be based in Runcorn.

Responsibilities

• Draft, review and improve validation documentation
• Execute all validation activities relating to facilities, processes, cleaning, and equipment, ensuring that all validation is performed in compliance to cGxp
• Planning and scheduling validation activities to maintain validation status
• Maintain compliance with Data Integrity Regulations and GAMP standards
• Investigate the root cause(s) of non-conformances and identify and ensure implementation of corrective/preventive actions to reduce non-conformances
• Support manufacturing and other operations in the development, implementation and maintenance of GxP standards
• Provide technical support to production to maintain GxP and production efficiency
• Complete risk assessments as required to ensure that the production equipment and production facilities comply with the relevant GxP and HSE guidelines
• Collate, review and interpret data from the QMS process
• Perform trend analysis of data and generate trend analysis reports and implement effective corrective measures as required
• Maintain an awareness of developments in the field of validation to ensure a continued provision of an up-to‑date service, providing guidance and training
• Occasionally work outside of hours

Qualifications

• Minimum of a Degree in engineering/science subject or extensive experience of working in a validation role within the pharmaceutical/healthcare related industry
• Experience and knowledge of cGMP and regulatory requirements for areas of expertise
• Experience of manufacture of sterile medicinal products
• Experience in thermal mapping and small instrument/systems (balances, pumps) is an advantage
• Clean room experience at least to Grade C is an advantage

No rota'd weekend working and no night shifts.

Benefits

• Contributory Pension Scheme (rises with service)
• Role specific tailored training and development plan
• Life Insurance (4 x salary, death in service)
• 25 days holiday (rises to 35 after 5 years service) and ability to buy/sell holidays
• Healthcare cashback scheme (including dental, optical & alternative therapies)
• Maternity, Paternity and Adoption Leave
• Professional fees paid
• Bike to work scheme
• Long Service Awards
• Employee Assistance Programme
• Free onsite parking and subsidised canteen
• Blue Light Card
• Company funded family days out

We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.