Analytical Instrument Qualification Specialist

Job Description

Unfortunately we do not offer sponsorship for this post

Full time - 39 hours per week (days shift)

Purpose of the post:

The post holder will be responsible for the planning and execution of Analytical Instrument Qualification activities within manufacturing areas as part of the Commissioning and Qualification (C&Q) team. The role is critical in ensuring that equipment is qualified, compliant, and fit for purpose in accordance with GMP requirements and company standards. At Eurofins this position is also known as PSS AIQ Specialist.

Typical Duties:

• You will support the delivery of Analytical Instrument Qualification (AIQ) activities for In-Process Technology (IPT) equipment, ensuring compliance with GMP requirements and project timelines.
• You will collaborate with cross-functional teams including Engineering, Quality, Operations, IT and Manufacturing to facilitate successful qualification and validation activities.
• You will prepare, review and execute qualification documentation, including protocols, reports, risk assessments and validation records.
• You will perform Installation, Operational and Qualification (IOQ) testing of analytical instruments and systems using approved digital validation platforms.
• You will assess the impact of equipment changes and modifications, determining appropriate qualification, requalification and testing requirements.
• You will investigate qualification deviations, document findings and support the implementation of effective corrective and preventive actions.
• You will act as a Subject Matter Expert (SME) for AIQ activities, supporting audits, inspections and continuous improvement initiatives while ensuring compliance with GMP, Data Integrity and Computerised System Validation requirements.

Qualifications

• You will hold a BSc degree in Engineering, Science or a related technical discipline.
• You will have experience in Computer Systems Validation (CSV), Equipment Validation or a similar qualification role within a regulated GMP environment.
• You will have a strong understanding of pharmaceutical and/or biotechnology regulatory requirements, including Annex 11, 21 CFR Part 11 and industry best practices relating to validation and compliance.
• You will have demonstrated experience analysing complex business and technical challenges, identifying practical solutions and supporting the successful delivery of validation and qualification activities.
• You will have excellent communication, facilitation, problem-solving and decision-making skills, with the ability to build effective relationships across multidisciplinary teams and stakeholders.
• You will have a results-driven approach, strong attention to detail and the ability to work collaboratively to deliver high-quality outcomes while meeting business and project objectives.

Additional Information

At Eurofins we are growing, innovating and always learning. We celebrate the achievements of our employees through annual long service awards, recognise our colleagues special life events, and we are committed to charitable causes through global fundraising activities.

As a Eurofins employee you will benefit from:

• Additional Annual Leave at Employees set service dates   
• Company Pension Plan
• Life Assurance Scheme (4 times annual salary)
• Healthcare Cash Plan (6+ months service)
• Enhanced Maternity, Adoption and Paternity Schemes
• Employee Assistance Programme – 24/7 confidential
• Health and Wellbeing Programmes
• Free parking
• Worldwide career opportunities
• We also have in place rewards recognising the great work our employees deliver, their dedicated service and celebrating special life events.

What Happens Next

Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. 

Your data 
As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
 
Closing Date
We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.
 
Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful. 

We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development.

We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.