Validation Engineer

  • Category
    Scientific - Validation
  • Location
    Swindon, Wiltshire
  • External Reference
    JN-112021-216497
  • OrganizationType
    IT

Validation Engineer
Swindon
6 month contract

As a Validation Engineer you will support the Commissioning, Qualification and Validation (CQV) activities within the Validation team. The role will be responsible for cGMP compliance of new and legacy facility, utilities and equipment, through the generation, execution and completion of CQV documentation and protocols, in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. Through testing, analysing and evaluating data gathered during site qualification and validation activities the Validation Engineer role ensures that systems and equipment are running according to specifications and operate within industry regulations.

The position is also responsible for the completion of assigned site Key Process Indicators, including Quality Records, CAPAs, and Action Items.

Responsibilities:
*Generation, execution and review of all life cycle validation documentation for the qualification of processes, facilities, equipment and utilities.
*To conduct qualification activities in adherence with up-to-date procedures and cGMP regulations and guidelines
*To assist in the investigation of deviations and provide support to the business in resolving quality issues.
*To take responsibility for Change Control actions or CAPAs with regards to Commissioning, Qualification and Validation.
*Prepare, review, and approve relevant change controls, CAPAs, and/or investigation reports supporting validation activities.
*To assist in keeping departmental KPIs to a minimum requirement.
*To archive all qualification documentation and be able to access information on demand
*To ensure that all documentation is generated, approved, executed and complete in a timely manner.
*To ensure that all tasks are carried out in an effective and efficient manner.
*To ensure that appropriate training records are maintained.
*To communicate effectively with other cross-functional teams on site.
*To supervise work of those undertaking validation activities.
*To maintain an understanding of current international regulatory, ISO, corporate and client requirements relevant to the section. To ensure compliance with the sections and site procedures.
*To liaise with the various departments involved in the qualification and validation work to ensure the efficient performance of the related tasks.
*To present qualification activities to an auditor during internal and external audits.
*Comply with cGMP requirements and company rules, policies and procedures.
*Make continuous improvements and embrace PPI.
EH&S:
*Understand emergency procedures and comply with safe systems of work.
*Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions always.
*Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications:
*Degree or relevant experience
*In-depth knowledge and understanding of cGMP.
*Knowledge of steam sterilisation, ISO 14644, clean utilities, thermal mapping
*Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
*Demonstrable experience in Quality Operations/Validation of equipment, utilities and facility validation
*Creativity, judgement and analytical thinking.
*Ability to work with critical timelines.
*An excellent planner, who can envision short-term milestones which the company must achieve to succeed in the long-term.
*Outstanding communication skills, both written and oral.
*The drive and maturity to lead assigned tasks, combined with the ability to support and interface effectively with projects and motivate cross-functional teams.

If you're an experienced Validation Engineer and meet the criteria listed, please APPLY NOW!


Spring Technology acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.

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To speak to a recruitment expert please contact Iain Mcculley