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  • Job reference number:15320691
  • Client ID:RI/JO-1712-365182_2
  • Posted on:07-FEB-2018
  • Job type:PERMANENT

Overall Purpose: Aerie pharmaceutical, a clinical stage Pharmaceutical start up in athlone are looking for an Experienced Validation engineer to join their team.

The Validation Engineer will design, coordinate and execute validation activities in support of the start-up of the Aerie Ireland manufacturing facility, and will be responsible for on-going re-validation of equipment and processes when the facility transitions from start-up mode to commercial supply. The Validation Engineer reports to the Technical Services Manager.

Essential Duties, Functions and Responsibilities:

  • Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
    • Prioritises safety and is diligent in the use of all appropriate safety tools and permits when validating equipment or processes – champions safe working always.
    • Develops and writes commissioning, qualification and validation documents following established standards and templates, including but not limited to the following:
      • Commissioning Test Scripts
      • Qualification / Validation Protocols and Summary Reports
      • Standard Operating Procedures
      • Risk Assessments
      • Specifications (URS)
    • Performs and assists with execution of validation protocols (IQ, OQ, PQ) associated with the start-up, and with the on-going re-validation of equipment and processes.
  • Provide technical assistance on current US FDA and EU validation requirements for aseptic processing and sterilisation.
    • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
    • Management of validation documentation through:
      • Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans
      • Review/approve execution of the validation/revalidation plans
    • Liaise with Engineers in relation to construction readiness and a schedule for systems/ equipment within areas of responsibility.
    • Manage onsite computer system validation and data integrity analysis and qualification
  • Member of the technology transfer team to lead validation activity as part of product analytical transfers to site.
  • Support validation impact assessments of proposed change via site change control processes.

Skills/Knowledge Required:

  • Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches.
  • Knowledge of leveraging test data from early stage project testing into later stages (e.g. FAT into SAT/IOQ)
  • Knowledge of regulatory validation requirements including FDA, EMA and all other applicable worldwide Regulatory requirements (ICH Q7, Q8, Q9)
  • Working knowledge of current CSV and data integrity industry requirements
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
  • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies.
  • Strong analytical skills, documentation skills and research skills.
  • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
  • Strong understanding of pharmaceutical industry regulatory requirements.
  • DoE knowledge desirable.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently
  • Strong team player.
  • Good proactive approach & manner
  • Knowledge and capability to perform validations of automated systems
Education Required :

  • Bachelors Degree (or equivalent) in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical)

Experience Required:

  • At least 10 years’ relevant experience in a pharmaceutical manufacturing environment, with at least 5 years’ experience in a comparable Validation Engineering role.
  • Experience of coordinating computer system validation and data integrity programs.
  • Must have experience working in a sterile manufacturing environment.
  • Requires prior experience performing validations of multiple systems and equipment in a time-sensitive start-up program.
Applicants should email their cv to or call me on 01-9476227 for a confidential conversation.

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