Your new company

Your new role

• Developing and executing validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.

• Collaborating with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.

• Performing risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.

• Creating and maintaining validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.

• Conducting periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.

• Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.

• Providing guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.

• Stay up to date with industry trends, regulatory changes, and advancements in computer system validation practices.

• Collaboration with vendors and suppliers to ensure compliance with validation requirements for third-party systems.

• Supporting regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation.

• Qualification of laboratory analytical instruments (e.g Cell Viability Analysers, Liquid Handlers etc.)

• Qualification of manufacturing automation systems (e.g DeltaV, MES etc.)

What you'll need to succeed

• Bachelor's degree in Computer Science, Engineering, or a related field.

• Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

• 5 Years experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.

• Familiarity with validation methodologies, including risk-based validation approaches.

• Proficiency in creating and executing validation protocols and documenting validation activities.

• Excellent analytical and problem-solving skills, with attention to detail.

• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.

What you'll get in return

• Highly competitive market rate
• Opportunity to gain experience with a well-established name which will stand to you in the future.
• Ability to work on the latest projects and with cutting edge up-to-date equipment and systems.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.