732-661-0400

Senior Validation Engineer

  • Location: Cleveland, OH
  • Type: Contract
  • Job #35304

Senior Validation Engineer- 6 MONTH CONTRACT ONLY ROLE; HYBRID ROLE!

 

  • Oversee and review validation area processes and procedures
  • Responsible for the theory and content of validation documents
  • Provide facility, equipment, and process qualification technical expertise
  • Author and approve validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes
  • Coordinate and lead validations to assure compliance with customers requirements, ISO 9001 & 13485, 21 CFR 210 & 211, ICH Q7, 21CFR 820, as needed
  • Interface effectively with management personnel in IT, Engineering, Quality, R&D, Sales, and other technical disciplineS
  • Perform, coordinate, and manage qualification testing
  • Coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 / ISO 13485, 21 CFR 210 & 211, ICH Q7 and 21CFR 820
  • Prepare, write, and review validation protocols, and documentation to ensure compliance and adherence to AMRESCOs SOPs, Customer specifications, ISO9001, ISO 13485, Ich Q7, 21CFR820 and other applicable regulations this includes regulatory bodies in the U.S. and International

 

Qualifications

  • Bachelors in Science, Engineering or Life Sciences (Chemistry, Bio, Physics, etc.) or equivalent experience
  • 6 to 8 years of experience in an Equipment and/or Process Validation Engineering role within a pharmaceutical or medical device company
  • Demonstrated track record managing multiple priorities; project management experience

 

Knowledge, Skills and Abilities

  • Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation, CFRs and their application to Medical Devices and pharmaceutical products
  • Knowledge of software packages supporting statistical data analysis, word processing, flow charting, and project management
  • Familiarity and understanding of manufacturing methods related to the production of medical devices, pharmaceutical and related products

 

INDMW1

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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