Role details

Validation Engineer

Inverness   •  Permanent

Bullet points

  • Engineering
  • Quality

About Our Client

Our Client based in Inverness is looking to recruit a Validation Engineer

Job Description

Our Client based in Inverness is looking to recruit a Validation Engineer

Under minimal direction and supervision, create and manage documentation required for validation execution activities - including but not limited to F.A.T, IQ and OQ. Ensure liaison with the engineering team to include the correct amount of technical input to the documents.

Manage and ensure the extended project team work to the Validation Strategy defined for Calibra MVL Project.

Provide the coordination, creation and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support the manufacturing of automated equipment.

In addition you will have to have an understanding of how the various pieces of automated equipment operate, and understand the principle of Validation and Engineering.

A Mid-Level Validation Engineer must have a Solid ability to do the following;

* Creation and execution of Validation plans and validation protocols for projects.
* Prepare and /or revise validation protocols/procedures as required.
* Review and execute qualification and summary reports, write and revise as needed.
* Work under the confines of the project schedule and budget.
* Analyse validation data, prepare reports, and make recommendations for changes and or/improvements.
* Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.
* Assist in defining and implementing acceptance criteria, specifications, and standards for each qualification activity.
* Interface with Manufacturing, Mechanical and Controls Engineering group.
* Have an understanding of PLCs and HMIs pertaining to validation activities.
* Innovate and use good judgement to incorporate applicable standards and regulatory requirements.
* Communicate ideas and comprehend information both verbally and in written form.
* Follow all policy and procedures to maintain ISO9000 Certification requirements.
* Prioritizes, plans, and organises work and workspace.
* Ability to travel (Europe or US) as required/agreed.

The Successful Applicant

The Ideal Validation Engineer will posses the following:-

Bachelor's degree or Equivalent
Technical understanding of medical equipment validation requirements
Strong communication and interpersonal skills. Coordinates all validation activities by constant communication with affected departments and personnel.
Knowledge of cGMP / Gamp5 requirements and current industry practices.
Demonstrate ability to work in a cross-functional team environment.
The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.

What's on Offer

Competitive Salary


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Click the Apply or LinkedIn button below or contact Blair Agnew on +44 141 331 7956 quoting job reference 13764031
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