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Validation Engineer

U270

We are currently looking to recruit for a Validation Engineer for our client who are a global pharmaceutical manufacturer based in Cambridge. The client are considering candidates on a permanent or long term contract basis.

Category:
Validation
Location:
United Kingdom
Date Posted:
31/07/2019
Days Remaining:
9
Employment Type:
Contract to Permanent

The main purpose of the role is to support the Projects Engineering Manager to ensure that the products are manufactured using equipment and facilities that complies with the GMP requirements specified by both the Regulatory Authorities and Company Policy. This includes supporting Research and Development, Production, Engineering and Business Systems, and other departments, as appropriate to develop and maintain validated systems.

SPECIFIC DUTIES & RESPONSIBILITIES:

Provide Validation input into engineering projects in accordance with GMP and departmental SOP’s. This will require supporting the Project Engineer or Project manager to ensure the completion of key milestones and the monitoring of documented evidence which verifies that such milestones have been met.

Support the introduction, modification and validation of new and existing equipment. This will include participation in multi-disciplinary teams and assisting in the development and approval of protocols, specifications, risk assessments, and reports to support these activities, in compliance with company and project specific standards.

Apply a “Risk-Based” approach to project and validation activities in accordance with industry guidance (GAMP5 and ICH Q9) to ensure validation and qualification activities are appropriate and focused on critical aspects.

Participate in the testing phases of a project, acting either as a Tester or a QA witness to verify test performance and outcome, and where necessary producing technical reports to agreed standards.

Work closely with the Validation Group to develop and ensure that a consistent and best practice approach is adopted with regard to generation of validation documentation and undertaking of validation activities (qualification and assessments), thus meeting validation requirements in accordance with regulatory requirements.

Liaise with equipment suppliers during key phases of projects to ensure completion of specific project deliverables, such as Vendor Assessments, Design Qualifications, and Factory Acceptance Test activities. Develop Vendor relationships to ensure these deliverables are met in accordance with defined project deadlines/milestones and delivered with the required quality.

Undertake any other reasonable tasks that are requested to help ensure that the highest standards of quality are achieved and maintained within the company’s validated systems.

 

 

 

 

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