Quality Validation Engineer

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Package: Salary plus 15% bonus and Car or Car Allowance

My client is a world-renowned pharmaceutical organisation recognised as a top employer in the UK. They offer an excellent working environment with competitive benefits and outstanding opportunities for career development.

They now have a pivotal role in ensuring the highest standards of quality at an innovative pharmaceutical manufacturing site. As a Quality Validation Engineer, you will be at the forefront of the Quality Validation program, focusing on key areas such as Process Validation, Control Strategy, Cleaning Validation, and Hold Time Validation. You will also manage the planning and execution of overall Validation processes for the site.

You will ensure validation documentation meets GMP Regulations and company procedures/policies, fostering a culture of compliance throughout the organisation. You will author, review, and execute validation and qualification lifecycle documentation while overseeing site validation activities.

Key Responsibilities

• Drive process improvements and support operations in delivering projects aligned with business needs
• Collaborate across all site functions to ensure compliance with local and company directives
• Create and maintain validation documents and quality strategic documentation
• Manage validation documentation including protocols and reports (URS, FAT, SAT, IOPQ, etc.)
• Generate monthly, quarterly, and annual KPI adherence reports
• Work with all departments to maintain validated status of processes
• Establish strong connections with local validation SMEs and global stakeholders
• Support Quality Management System activities (audits, CAPA, Deviation, Change Control)
• Develop and modify SOPs, Work Instructions, and guidelines for validation policies

About You

• 5+ years in equipment and process validation within a GMP pharmaceutical environment
• Strong understanding of GMP, Risk assessment, and Data Integrity
• Extensive knowledge of validation and qualification processes
• Degree in a related science or engineering field, or formal qualification in validation or quality
• Experience in aseptic production and biologics and/or Project management experience are desirable (desirable)

If you're interested in the above role then please click apply or get in touch to discuss further.

Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.