Job Detail

Location Waterford
Salary Negotiable
Posted
Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie

Validation Engineer (Med Device Cleanroom)

Cleanroom Validation Engineer

My client is Waterford based Medical Device company with exceptions growth opporunity within the organization! I’m pleased to be offering a new role for an experience Medical Device Cleanroom Validation Engineer to join on a permanent basis.

Duties of the role:

  • Serve as a subject-matter expert on validation activities during regulatory agency inspections
  • Support NPI team in the execution of Performance Qualification (PQ) for clean room processes as per the project schedule.
  • Involved with conducting investigations into non-conformances and customer complaints, performing internal audits, preparing SOP’s and templates, assisting in Validations and troubleshooting Quality issues.
  • Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment.
  • Support deviation investigations throughout the manufacturing site.
  • Manage several projects simultaneously and coordinate multiple, changing deadlines
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPA’s as required.
  • Create concise and accurate on-time technical reports. Clearly communicate results internally and to customer through the use of quality tools and statistical techniques.
  • SME for appropriate statistical techniques to monitor process performance such as SPC, Cp, Cpk, R&R analysis, sampling techniques and other statistical techniques.
  • Creates and evaluates metrics to drive tangible quality improvement through the team.

Requirements of the successful candidate:                

  • Degree in Engineering; Mechanical/Manufacturing/Process or similar
  • 5 years’ experience in Validation Engineering; Exposure to SPC and validations
  • Knowledge of Reg requirements ISO 9001-13485 CFR 820 is essential
  • Knowledge of cleanroom environmental monitoring
  • Knowledge of ISO 31000 & ISO14644
  • Experience in the use of techniques such as Design of Experiments, Gauge R&R, Test Method Validation, sample size justification to support design changes, validations, deviations

For further information on this Validation Engineer role, please contact Marchon Monroe on 086 044 9473/ talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Marchon Monroe

JOB-11399

Validation Engineer (Med Device Cleanroom)

Marchon Monroe

Role Type Permanent
Contact Marchon Monroe
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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