Validation Specialist

Hobson Prior are working with a top pharmaceutical organisation who are looking for a Validation Specialist to join their manufacturing centre on a permanent basis in Braintree. This is a new opportunity to be part of something challenging and unique where you will drive the completion of validation activities.

Job Responsibilities:

Validation/Technical

• Accountable to drive to completion validation activities including, input into defining validation requirements to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP.
• Maintain up-to-date industry best practice knowledge of validation trends.
• To work with validation contractors to support commissioning and start-up activities ensuring vendors have been QA assessed, work is witnessed and is to a standard that can be leveraged for validation purposes in accordance with ASTM E2500 to improve efficiency.
• Responsible to ensure all activities on site comply with current or proposed standards and regulatory compliance requirements.
• Supervise validation exercises performed by third parties to ensure work is completed following Data Integrity requirements (ALCOA Standards).
• Any other assigned duties.

Non-Technical:

• Work within the organisation's multi-disciplinary team and matrix environment to ensure successful delivery of projects.
• Establish links with outside parties to benefit the organisation's validation processes including identifying and evaluating new technologies where appropriate.
• Personal development - Pursue a programme of continuous personnel / professional development in accordance with any relevant professional registration or statutory requirements.
• Travel within the UK and internationally to attend meetings and perform activities as required.
• Any other assigned duties.

Key Skills:

• Able to evaluate complex situations and determine appropriate solutions in a pragmatic, professional manner.
• Project ownership and pride in its delivery.
• Having a passion for delivering excellent customer service in a cost-effective way.
• Flexibility towards work assignments and new learning.
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
• Excellent oral and written communication and presentation skills.

Requirements:

• BS or MS degree in life science / engineering or broad knowledge of the commissioning and qualification of equipment and utilities in a regulated environment including:
  -Compressed Gases, Purified Water/Water for Injection, Pure Steam & HVAC
  -Biological Upstream process equipment e.g. Bioreactors & Single use mixing systems
  -Biological Downstream process equipment e.g. TFF & Chromatography
  -Quality Control testing equipment
• At least 5 years GMP experience in Biopharmaceutical products with significant validation experience, or combination of Validation and Engineering/Commissioning experience
• Experience of collaborating successfully with a team of validation engineers, SMEs, specialists and a network of external contracted resources.
• Experience of the successful interface of Facilities, Quality, Operations and Information Technology groups, to develop requirements, establish programs and manage day-to-day operation.
• Understanding of the validation requirements of utility systems, process instrumentation, Biomanufacturing processes, automation (PLC) systems, and analytical equipment.
• Experience of establishing function-appropriate qualification / verification programs for laboratories (Process, Product development and Quality Control).
• Experience in direct interaction with the regulatory authorities.
• Experience in direct interaction with clients and collaborators.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.