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Validation Engineer

  • Location: Montrose
  • Salary: Negotiable
  • Job Type:Contract

Posted about 1 month ago

  • Sector: Non-core sector
  • Contact: Shaun Lamb
  • Contact Email: slamb@nrl.co.uk
  • Contact Phone: 0141 226 8156
  • Duration: 12 Months
  • Start Date: ASAP
  • Expiry Date: 11 June 2021
  • Job Ref: 1035442M

NRL’s client based in Montrose is looking to recruit a Validation Engineer for an ongoing contract on an Umbrella or PAYE basis. Starting asap - candidates must have experience within pharmaceutical.

About the role

  • To communicate with all other project team members.
  • To organise and lead Validation working parties, providing a timely validation co-ordination service to the Project Manager and Project Sponsor.
  • To provide information to the Validation and Project Team on the current regulatory and company standards that must be met to maintain compliance.
  • To prepare and issue Validation Master Plan(s) and Summary Report(s).
  • Support the preparation and issue of validation documentation associated with Validation, as appropriate for each validation exercise.
  • To ensure all Validation activities and documents are authorised and appropriate compliance approval is gained.
  • To ensure that all Validation activities are carried out and reported in a timely manner.
  • To compile a Validation Master File for each Validation exercise or group exercises as appropriate.
  • To assure compliance through auditing.
  • Through effective communication and training initiatives develop staff within Project and Validation Teams to ensure that validated projects are carried out in accordance with GSK Policies and Procedures.
  • To sign off Project Change Controls to confirm no adverse effect on GMP or validation status.
  • The Validation Representative has a number of key responsibilities to the Project Team:
  • To ensure that all Validation issues are addressed through all phases of the project life cycle, across all appropriate disciplines and include:
  • In conjunction with the Quality Assurance Representative, providing a proactive contribution to, and act as a focus for, questions relating to GMP, cleaning, analytical information, specifications, control of change, etc.
  • Ensure that the Project Team is aware of the latest guidelines on validation, control of change, etc.
  • Advise on cleaning validation.
  • To ensure that all activities within this responsibility are undertaken in a timely manner to allow the smooth progression throughout the Project from Initiation to Handover.
  • To influence the design, to ensure that the new or modified plant is capable of being operated appropriate to the process to the appropriate quality.
  • To ensure that all Validation protocols are produced and implemented through all phases of the project including:
  • Provide an outline of likely validation requirements for the project and take a lead role in the preparation of validation master plan.
  • Ensure that the project design and documentation meet the required standards by an appropriate level of auditing.
  • Monitor progress against plans and protocols and provide key milestone reviews.
  • Approve progression to the next validation phase.
  • Report deviations or delays and support development of checklists and test rationales.
  • Meet the requirements of any registration or regulatory bodies.
  • To ensure that all appropriate Validation staff are kept fully aware of the project, including:
  • Manage the interface with all Quality functions to ensure that appropriate personnel are involved where relevant.
  • Ensure that process related information and proposed process changes are communicated
  • Regulatory strategy
  • Project programme, including validation and commissioning plans
  • Suspension or changes to existing routine operations
  • Plant layout changes/implications

What you will need?

  • HND level qualification or equivalent in either a science or engineering subject
  • expert knowledge of validation in alignment with QMS, cGMP, GQLP and cGxP requirements
  • Abroad multidisciplined knowledge of computer hardware, software, relational databases and other technology
  • Experience in a regulated quality driven process environment
  • Specialist knowledge of validation