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SENIOR VALIDATION ENGINEER - MIDLANDS

 

Company:

ICDS RECRUITMENT
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Job Reference Number

14566477

Client ID:

RI/EM12505
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Posted On:

Feb 7 2012

Location:

WESTMEATH
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Job Type:

Permanent

Salary:

NEGOTIABLE
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Benefits:
  • CAR PARKING
  • PENSION / PRSA
  • BONUS
  • LIFE ASSURANCE
  • VHI
  • PAID HOLIDAYS
Senior Validation Engineer with 8+yrs Quality / Process Development / Process Validation / Manufacturing engineering experience in the medical device / pharmaceutical industry

Principle Accountabilities

  • Use quality engineering techniques to ensure products released for distribution meet their intended performance requirements for safety and efficacy.
  • Data collection, data interpretation and analysis, root cause analysis and report writing.
  • Assist in the design, analysis and approval of IQ, OQ, PQ, and PV protocols and reports.
  • Communicate and teach validation approach and requirements.
  • Maintain master validation plans.
  • Assess proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.
  • Participate and provide assistance and technical support on technical project teams as subject matter expert on process validation regulations/procedures.
  • Support technology transfer of processes.
  • Critically review and provide support for validation sections of regulatory submissions where required
  • Work closely with Regulatory, Operations and R&D Departments.
  • Quality and risk management.
  • Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
  • Work on significant problems of diverse scope in which analysis of situations or data requires an in-depth evaluation of variables.
  • Provide quality engineering support in supplier quality assessments and issues.
  • Identify continuous improvements opportunities where possible and take part in improvement projects as assigned
Minimum Requirements:

  • B.S. or M.S. in Engineering , (Preferably Chemical or Mechanical) or equivalent discipline
  • 8 + years of Quality, Process Development, Process Validation, or Manufacturing engineering experience in the medical device and/or pharmaceutical industry.
  • Ability to troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications, capital projects, and technology transfer.
  • Ability to function in a fast-paced, highly technical environment.
  • Strong problem-solving and critical thinking skills.
  • Sound understanding of engineering principles and their creative application on-the-job.
  • Strong mechanical aptitude.
  • Thorough knowledge of industrial process design and engineering techniques.
  • Ability to understand and follow machine drawings, blueprints, and process diagrams.
  • Computer skills required, with strong proficiency in Microsoft Office software. Skill with Visio is desirable.
  • Excellent communication skills.
  • Excellent organizational skills with ability to prioritize and work effectively on multiple tasks.
  • Ability to work independently (or with minimum supervision), efficiently and be results oriented.
  • Solid mentoring skills in developing less experienced engineers.
  • Good numeracy skill with ability to perform statistical analyses and design experiments.
  • Experience with Minitab, or other statistical software packages preferred.
  • In depth knowledge of Good Manufacturing Practices GMP, Quality System Regulations and ISO quality standards.


Preferred Requirements:

  • Strong manufacturing experience, particularly in relation to the Quality and validation requirements of the business.
  • Project Management Experience
  • ASQC/ Green Belt/Black Belt certification preferred not required.
  • Ability to prioritise and execute tasks in a high-pressure environment.
  • Ability to analyse metrics.
  • Good written, documentation, and oral communication skills.
  • Proven analytical and problem solving skills.
  • Exceptional customer service orientation.
  • Ability to interact with employees from all levels within the company.
  • Previous experience with EO sterilisation would be distinct advantage

    www.icds.ie