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Validation Engineer

Location: Suffolk Salary: in scope
Sector: Process Controls & Automation Type: Contract
Contact: Adrienne Kettlewell Job Published: 24 days ago

Validation Engineer

Duties -

  • Responsible for qualification and validation activities in accordance with corporate standards, site procedures, User requirements, equipment specifications and regulatory guidelines thereby maintaining cGMP for the site

  • Provides technical guidance with respect to Validation requirements

  • Reports to Validation Team Lead

  • To undertake validation duties assigned by the Validation Manager or Team Leader

  • Provide support and guidance to Haverhill site projects, operations to meet the quality and compliance requirements of the site and the wider company with respect to Validation

  • To prepare, execute and report validation documentation

  • Review and approve validation deliverables and provide guidance in their creation

  • Supports in the review and approval process for Quality Reviews to support adherence to their respective schedules

  • Drives continuous improvement

  • Keeps up to date on regulations and legislation and supports implementation of changes on current operations.

  • Identifies compliance gaps within their own area of responsibility and proactively works towards their remediation

  • Leads investigations and identifies root causes and appropriate preventative actions

  • Ensure all corrective and preventative actions in their value stream are completed within the agreed timelines

  • Provides support during internal and third party audits

  • Supports maintaining a constant state of inspection readiness within area of responsibility

  • May coach or supervise other staff and contractors as required

  • Maintain core training and prior to conducting any activity ensure you are trained in the current version

  • Responsible for personal safety and that of others, reporting all accidents and unsafe acts and conditions

Relationships

  • Work in close collaboration with primary customers, Engineering, Production, Development Sciences and QC

  • Has frequent inter-departmental and inter-site contact. Actively shares best quality and safety practices across the site and seeks input from across the Sanofi network

MUST HAVE 

  • Minimum of 3 years’ in a validation role.

  • Good experience in equipment qualification on manufacturing & lab equipment.

  • Experience in cleaning validation would be desirable but not essential.

  • Some CSV experience would be good not essential given role will be strictly qualification activities.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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