Senior Validation Specialist, Csv - Oxford, United Kingdom - oxfordbiom

oxfordbiom

Verified Company

Oxford, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 teamorientation with a proven ability to coach/mentor and lead less experienced members of the validation team in projectrelated activities
Proven ability to work in multiproject 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 35hour 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