| Location: Suffolk | Salary: in scope |
| Sector: Process Controls & Automation | Specialism: |
| Type: Contract | Contact: Adrienne Kettlewell |
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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