Validation Specialist

We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you.

We are currently recruiting for a Validation Specialist to join the team.  This opening provides an exciting opportunity to participate in high value projects, working alongside cross-functional teams to deliver company goals, contribute to the delivery of major customer projects and the ensuring of regulatory compliance for GMP manufacturing.

Operating as part of the Validation Department, the Process & Sterile team is responsible for the generation, execution and reporting of deliverables relating to GMP manufacturing processes (Process Validation), validation of sterile processes (Media Fills, VHP cycle qualification, dry heat cycle qualification), and validation of supporting processes (decontamination assurance).

Your responsibilities in this role would be:

• Preparation and execution of validation protocols (Process Validation, Sterile Processes, and associated activities) and subsequent reporting.
• Active participation in cross-functional meetings and discussions to provide validation support to both internal and customer SMEs.
• Ownership of quality records (Deviations, Change Controls and CAPAs) on behalf of the Validation Department.
• Supporting Validation activities during Technology Transfer of new manufacturing processes, including validation of decontamination processes and manufacturing equipment qualification, as required.
• Contributing to the maintenance of department KPIs relating to validation of equipment, facilities, utilities, processes and computerised systems.

We are looking for:

• A Degree (or equivalent) in a Science / Engineering or related discipline
• A working knowledge of the current standards, GMP regulations and industry guidelines as they relate to qualification/validation of manufacturing processes, sterile processes, and manufacturing systems.
• Demonstrable experience of the validation of manufacturing processes and sterilisation processes, in a biopharmaceutical, pharmaceutical or related industry.
• Experience of working within a GMP Quality Management System.
• Highly organised individual with a proven ability for problem-solving, thoroughness and good teamwork.
• Demonstratable effective oral, written & interpersonal skills.
• The ability to adapt to changes in priorities and meeting timelines.
• Other desirable experience includes the generation/execution of equipment validation lifecycle documents (URS, DQ, IQ, OQ & PQ) and a working knowledge of Cleaning Validation.

About Us:

We are a quality and innovation-led cell and gene therapy CDMO with a mission to enable our clients to deliver life changing therapies to patients around the world.

Our innovative solutions and proven expertise allow our clients in the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients.

The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world’s worst diseases and medical conditions.

What’s in it for you:

• Highly competitive reward packages
• Wellbeing programmes
• Development opportunities
• A 35-hour working week
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Deliver Innovation, Be Inspiring and Have Integrity
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

Collaborate. Contribute. Change lives.