Senior Validation Specialist, Csv

**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 Sr Validation Specialist with extensive experience within CSV 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 validated state for all GxP computerised systems, including Information Systems (Cloud, on Premises), computer controlled analysis equipment and automated devices
- Planning and managing validation effort for multiple concurrent initiatives (resource estimation, planning and monitoring)
- Advising & assisting stakeholders on all validation deliverables & activities
- Creating, reviewing, approving and executing validation plans & protocols (computerised systems) to defined timelines
- Managing validation reviews
- Supporting GxP operational processes including Change Control, Configuration Management, Deviation & CAPA
- Demonstrating and fostering a culture of continuous improvement in support of the business aims/objectives and identifies, investigates and implements efficient, effective and compliant ways of working.
- Authoring, implementing and training cGxP CSV Processes
- Remediating legacy computerised systems

**We are looking for**:

- A degree (or equivalent) in a related discipline
- A high standard of knowledge of the current standards and regulations and guidelines as they relate to qualification/validation of computer systems (added)
- Extensive experience within CSV Validation within GMP manufacturing/analytical environments (adjusted for compliance)
- Experience within biopharmaceuticals or pharmaceuticals sectors is preferred (if not required better to leave out)
- Experience with Agile preferred
- Relevant industry training & qualifications advantageous (e.g. ISPE / GAMP, ISTQB)
- Strong team-orientation with a proven ability to coach/mentor and lead less experienced members of the validation team in project-related activities
- Proven ability to work in multi-project environments, identify priorities and work collaboratively, utilising effective time management skills
- Excellent spoken & written English communication and proven influencing skills at varying levels within the organisation, across functions and multiple project teams.

**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