Validation Specialist

2 weeks ago

Oxford, United Kingdom oxfordbiom Full time

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.

Manufacturing Science & Technology (MSAT) and Validation are two groups within operations that are enabling the introduction of new facilities, equipment and processes to Oxford Biomedica. We contribute to the delivery of customer projects, and to the future growth of the company.

**Your responsibilities in this role would be**:

- Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support GMP requirements
- Preparation and execution of validation protocols (equipment, computerised systems and processes)
- Assisting out all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules.
- Arranging specialist services to maintain calibrate and qualify specialist equipment.
- Directing, instructing and supervising OEM technicians, fitters and contractors as required when external support is utilised for qualification activates.
- Maintaining validation equipment in a state of calibration and compliance to support the company’s validation efforts.
- Contribute to proactive management of asset preservation, energy reduction initiative etc.

**We are looking for**:

- A Degree (or equivalent) in a Science / Engineering or related discipline
- A working knowledge of the current standards and regulations and guidelines as they relate to qualification/validation of equipment/systems, facilities, utilities and processes.
- Demonstrable experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation/execution of lifecycle documents (URS, DQ, IQ, OQ & PQ )in a biopharmaceutical, pharmaceutical or related industry
- Proven problem-solving skills/diagnosing faults/resolving qualification issues.
- Demonstratable effective oral, written & interpersonal skills
- The ability to adapt to rapid changes in project priorities and meeting aggressive timelines.

**About Us**:
We are an innovative leading viral vector specialist focused on delivering life changing therapies to patients.

Our innovative solutions and proven expertise allow us and our customers, 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.

We work together, motivated to make a difference, and so can you.

**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

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