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Senior QA Validation Engineer (cGMP – Pharmaceutical) JD818636

JD818636

DPS is seeking an established and knowledgeable QA Validation Engineer to work with a BioPharma client in the Boston, MA area. Successful candidates should have previous experience managing cGMP compliance of process, facility, utilities, equipment, method and computer system validation. This individual will be responsible for ensuring review and approval of all validation records and documentation (i.e. process validation, cleaning validation, computer system validation, method validation/transfer, and equipment lifecycle documentation).

Category:
Engineer Validation & Commissioning
Location:
Massachusetts
Years of Experience Req.:
8+
Date Posted:
01/01/2019
Days Remaining:
40
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior QA Validation Engineer (cGMP – Pharmaceutical)       JD818636

Boston, MA area

 

DPS is seeking an established and knowledgeable QA Validation Engineer to work with a BioPharma client in the Boston, MA area.  Successful candidates should have previous experience managing cGMP compliance of process, facility, utilities, equipment, method and computer system validation.

 

This individual will be responsible for ensuring review and approval of all validation records and documentation (i.e. process validation, cleaning validation, computer system validation, method validation/transfer, and equipment lifecycle documentation).

 

Responsibilities:

  • Provide QA oversight of commissioning, qualification and validation activities to GMP manufacturing facility.
  • Responsible for managing the review/approval of design and commissioning documentation, validation protocols, reports and support records to certify compliance with specifications and procedures.
  • Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
  • Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
  • Responsible for supporting internal and external inspections as a Subject Matter Expert for Quality Assurance Validation.
  • Must have strong understanding of Computeriz301290.941617ed and Automated Systems Validation Engineering lifecycle.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • Minimum of 5+ years of Quality Assurance/Validation experience in the biotechnology or pharmaceutical industries.
  • Experience in IT systems, automation, operations and manufacturing within the biotechnology industry and in new manufacturing facility start-up environments is required.
  • Must have demonstrated understanding of cGMP.Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
  • Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
  • Proven ability to manage projects while meeting all deliverables and timelines.
  • Strong knowledge of global regulatory requirements for validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
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