Job Title
Senior Equipment & Process Validation Engineer


Location: Remote based role. The ability to be onsite in North West Ireland if required is essential. Candidates not based in Ireland will not be considered.

Contractor Opportunity

As the Senior Equipment & Process Validation Engineer you will be responsible for the remote management of Equipment and Process Validation requirements for SL Controls client’s German operation. The role will have a strong documentation focus.

Responsibilities

  • Managing and co-ordinating the preparation, review and approval of the Validation Master Plans.
  • Managing and co-ordinating of all validation strategies and deliverables.
  • Development and maintenance of internal validation policies and procedures based on best international standards and practices.
  • Auditing of internal projects against internal validation policies and procedures.
  • Managing and co-ordinating the preparation, review and issuing of validation protocols and reports.
  • Managing and co-ordinating validation documentation including risk assessments, traceability matrices, and validation reports.
  • Managing and co-ordinating the review and approval of specifications associated with Equipment and Processes
  • Managing, co-ordinating and directing all validation and revalidation activities.
  • Reviewing, managing and approving change control forms for Validation/Compliance implications.
  • Managing and co-ordinating routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise.
  • Updating existing quality documentation related to validation activities.
  • Provide technical direction and hands-on assistance for testing projects.

Requirements

  • Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline.
  • Over 5 years’ experience as an Equipment Validation Engineer in the Pharmaceutical or related Healthcare industry.
  • Experience with GMP Fill and Finish systems would be highly desirable.
  • A strong understanding of manufacturing processes and related process equipment.
  • Proven ability to solve complex technical and equipment qualification challenges using a rational scientific approach.
  • Excellent understanding of validation concepts and documentation.
  • Experience of GxP Computerised Systems.
  • Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
  • Familiar with the GAMP5 guidelines.
  • Excellent communication skills, including ability to advise and influence.
  • Excellent attention to detail.

Why Choose This Role & SL Controls

  • An excellent compensation package which rewards high performers
  • The opportunity to work clients who are global leaders in their field
  • A supportive environment committed to employee development and wellness
  • The opportunity to work with, help develop and improve upon industry leading technology solutions
  • A collaborative and open culture where you are valued and can contribute to company initiatives and growth

About SL Controls

SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets. Over the past 18 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.

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