Job Title
Validation Engineer


Location: Cavan
Contractor Opportunity

As the Validation Engineer you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.

Responsibilities

  • Managing and co-ordinating the preparation, review and approval of the Validation Master Plans
  • 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, Processes, Products and Computerised Systems
  • Participates in CAPA, periodic review and remediation activities where required
  • Co-ordinate and Assist in the development and execution of Validation protocols, including IQ, OQ, PQ, and work closely with Quality and Production to lead execution
  • Reviewing vendor validation documentation
  • Addressing customer feedback and providing progress updates to customers
  • Liaising with customer departments

Requirements

  • A relevant science or engineering tertiary qualification
  • At least 3 years’ experience in the pharmaceutical or life sciences industry with experience in Process and Equipment Validation
  • Experience of GxP Computerised Systems and GAMP 5 a plus
  • Ability to apply and incorporate regulatory standards, rules and guidances. (e.g. FDA, EU, ISO, ISPE etc.)
  • Demonstrated understanding of manufacturing processes and related process equipment
  • Proven ability to solve complex technical and equipment qualification challenges using a rational, scientific approach
  • Proficiency with Quality by Design (QbD) concepts and design of experiments a plus
  • Familiarity with statistical process control (SPC) and statistical analysis software is a plus
  • Excellent communication skills, including ability to advise and influence
  • Excellent attention to detail
  • Excellent understanding of validation concepts and documentation
  • Evaluation and review of validation data
  • Should be based within a commutable range or else willing to re-locate for 1 year period
  • Expected to be on site during the project with minimal travel required for the execution of FAT’s

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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