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Production Process Validation Engineer

Job Title: Production Process Validation Engineer
Contract Type: Contract
Location: International
Industry:
REF: 86457
Job Published: 26 days ago

Job Description

Contact: Anna McGowan
Email: anna@hero.ie
Telephone: 091730022

Production Process Validation Engineer

Our client, an engineering company in Germany are currently looking to recruit a Production Process Validation Engineer for their site, for an hourly contracting basis.

The successful candidate will
  • Evaluate and calibrate the equipment and procedures used in development and production of a variety of products.
  • Establish validation standards, develop testing protocols, prepare equipment, conduct tests, document test results, maintain records for later analysis and report findings.
  • Make adjustments to equipment or processes that require improvement, decide if equipment needs to be repaired or entirely replaced.
  • Must coordinate with other personnel or departments who will be affected by testing.
  • Other duties include preventative maintenance, maintenance of testing equipment and overseeing the inventory of validation supplies.
  • Address corrections and corrective actions concerning production process validation.
  • Contribute to closing NCs.
  • Contribute to closing CAPAs.
  • Implement sustainable, best practice protocols.

Special Requirements
  • Bachelor's degree in Engineering is the minimum qualification for entry level validation technician positions. Completion of a master's degree program can be of benefit.
  • Minimum of 2 years' experience within the Medical Device industry
  • Knowledge of FDA 21, CFR 820 and ISO 13485
  • Additional knowledge and skills may include computer programming languages, or a biological or medical background or laboratory experience.
  • Familiar with authoring protocols and reports; specific to the validation of test methods
  • Understands statistics and how they pertain to test method validation
  • Experience in performing test method validation protocols
  • Experience working with suppliers for the development of inspection methods
  • Understanding of correlation studies between two similar inspection method / techniques
  • Experience / Understanding of various inspection techniques and inspection tools required
  • Direct experience performing test method validation(s)
  • Must understand technical oral/written English
  • Project and time management skills
  • Excellent technical writing skills


For further information on this Production Process Validation Engineer role in Germany please contact Anna McGowan on 091730022 / anna@hero.ie
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