Validation Engineer
6 months
IR35 - INSIDE
50-55PH
To carry out all Commissioning and Qualification (C&Q) related activities, including process plant, utilities and computer systems and to ensure compliance with global cGMP, safety and environmental expectations and legal obligations.
DUTIES-
- Work to and deliver agreed C&Q plans that meet global cGMP expectations and align to the strategic direction of the site.
- To carry out the C&Q aspects of changes and projects through direction from the C and V manager.
- To interact with external customer groups in development and alignment of C&Q strategies and to resolve differences of opinion in a satisfactory and compliant manner.
- Resolution of deviations and issues associated with C&Q activities and to support the resolution of deviations and issues that have a C&Q component.
- To act as a C&Q subject matter expert at the site and in support of the Health Division as required.
- To ensure changes to the site IT systems remain in GMP compliance.
- Management: In consultation with Production, Engineering, Development, Compliance and Quality representatives, to formulate a strategy for the C&Q requirements, based on previous C&Q experiences and cGMP expectations, company policy, guidelines and procedures and the needs of the particular system.
- Provide / approve C&Q time estimates for each change / project.
- To prepare C&Q plans in line with project requirements
- To ensure that C&Q protocols and reports are aligned to latest thinking on delivery of compliant C&Q.
- To perform risk assessments related to C&Q activities including the evaluation of change management activities.
- Assist in qualification of production and laboratory equipment and hardware/software with authority to approve non-critical deviations and give protocol approval.
- In combination with the Commissioning and Validation Manager, establish and maintain a structured qualification and validation archive, in compliance with relevant procedures. Maintain a qualification and validation library.
- Responsible for ensuring new or modified IT systems are qualified appropriately through close liaison with the Business Information Systems group.
- To take on any other duties which are within the employee's skills and abilities whenever reasonably instructed.
- To carry out any other duties which are within the employee's skills and abilities whenever reasonably instructed.
skills required-
Experience of C & Q project work in a GMP environment
A degree in a Chemistry / Engineering related subject
Detailed knowledge of pharmaceutical engineering and manufacturing functions
Guidant is acting as an Employment Business in relation to this vacancy.
