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PROCESS / VALIDATION ENGINEER - 12MTH CO

 

Company:

ICDS RECRUITMENT
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Job Reference Number

14566490

Client ID:

RI/EM12401
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Posted On:

Feb 7 2012

Location:

WESTMEATH
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Job Type:

Contract

Salary:

NEGOTIABLE
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Benefits:
  • CAR PARKING
  • PAID HOLIDAYS
Process / Validation Engineer required for 12 month contract with multinational manufacturing company in Athlone.

General Function
The management and delivery of validation expertise to manufacturing equipment, processes and products. Responsible for delivering and validating capital projects and ‘best practice’ methodologies that support highly efficient processes and consistent product output to the quality satisfaction of all customers internal and external.

ESSENTIAL FUNCTIONS:

  • Plan and execute validation activities in areas assigned.
  • Software validation, PLC , vision systems algorithm etc
  • Plan and execute capital projects.
  • Execute root cause analysis, establish and implement optimal solution to machine and process problems.
  • Project manages all activities in a responsible, professional and proactive manner.
  • Lead teams in the planning and execution of validation activities.
  • Execute other duties as assigned by plant management.


REQUIREMENTS:

  • Bachelors degree in a Science/Technology/Engineering related discipline (e.g. Electrical or Mechanical Engineering);
  • Well developed analytical, numerical and computer skills and have the ability and versatility to combine hands-on validation activities with theoretical knowledge and expertise.
  • Significant relevant experience in Plastics technology and/or Medical Device / Pharma is required (3~5 years minimum).
  • Minimum 5 yrs relevant and recent experience in process / validation engineering in a highly regulated environment ;
  • Proven track record in the execution of protocols and validations to FDA requirements.
  • Possess proven problem solving skills.
  • Possess a track record of project managing and implementing of capital and cost saving projects;
  • Possess project management and project execution experience demonstrating a successful track record in timely project delivery.


Responsibilities:

  • Planning and execution of Protocols and Validations to FDA requirements;
  • Establish and develop strong and effective working relationships at all levels to ensure maximum effectiveness;
  • Manage the implementation and validation of Capital Projects using effective Project Management tools and techniques;
  • Provide technical back-up as required to resolve processing problems;
  • Monitoring of materials, equipment and process flows to ensure high levels of performance and OEE;
  • Co-ordinate the planning and execution of line trials and the security of line samples and emanating data;
  • Ensure Capital Project spend forecasting is accurately managed and delivered on;
  • Support the sustainable implementation of Control systems for tooling in assigned areas;
  • Engage with the appropriate personnel in the resolution of Technical, Quality and Manufacturing issues in assigned areas.
  • All projects shall be managed and driven in a proactive and responsible manner;
  • Pursue the achievement of optimum performance on a continuous basis;
  • Achieve all targets and standards as set by the Management team;
  • Ensure the full understanding of and implementation of the company’s GMP Policy;
  • Ensure the Health & Safety of oneself and others at all times and communicate potential hazards to the appropriate personnel.
www.icds.ie