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Process/Validation Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Carlow
  • Sector: Other
  • Date posted: 04/10/2017
  • Job reference: J375203A

Validation Engineer

Validation Engineer required to join a leading biotech facility in Carlow. The role will be responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.

This role will report to the Associate Director of Technical Engineering and will lie within the Technical Engineering organisation.

Responsibilities

  • Serve as technical support for manufacturing and new product introduction
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
    Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports,
  • Execution/development of change controls
  • Contribution to Kaizen events as appropriate.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.;
  • Implement subsequent corrective action through the change management system.
  • Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.

Qualifications

  • Typical Minimum Education:
  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Typical Minimum Experience:
  • 5+ yrs experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Equipment and process validation essential
  • Sterile filling processes and equipment ideal or Pharma/healthcare environment.
  • Experience in Process Performance Qualification protocol and report generation
  • Good understanding of Regulatory requirements and experience in writing filings
  • Quality risk management knowledge/experience

For more info contact Paul on 01 6455 250 or email

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