CSV Engineer

Hobson Prior are working with a top pharmaceutical organisation who are looking for a CSV Engineer to join their manufacturing centre on a permanent basis in Braintree. This is an exciting opportunity that is challenging and unique where you will be accountable to drive the completion of computer systems validation activities.

Job Responsibilities:

Validation/Technical

• Drive to completion validation activities including, input into defining validation requirements to ensure compliance and meet the requirements of EudraLex Vol. 4 Annex 11, FDA 21CFR Part 11 and comply with Data Integrity expectations, described in the MHRA 'GXP' Data Integrity Guidance.
• 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.
• Maintain up-to-date industry best practice knowledge of validation trends.
• 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).
• Accountable to work with vendors to resolve issues and ensure complete deviation reporting investigation and closure for validation activities.
• 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.
• To 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:

• Ability to evaluate complex situations and determine appropriate solutions in a pragmatic, professional manner.
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Excellent interpersonal, written, and verbal communication and presentation skills.
• Excellent oral and written communication and presentation skills.

Requirements:

• BS or MS degree in life science / engineering /Computer Science or Broad knowledge of the commissioning and qualification of computerised systems in a regulated environment including:
  - Infrastructure
  - Enterprise wide applications and systems hosted by and external vendor including cloud-based systems (e.g. SAP, Q-Pulse)
  - Control systems (dedicated integrated controllers, distributed control systems, PLCs, SCADA, Server based systems)
  - User Spreadsheets (and similar)
• At least 7 years GMP experience in Biopharmaceutical products with significant computer system validation 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 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.