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CQ Lab Validation Engineer

Company: PQE Group
Location: Morrisville
Posted on: June 25, 2022

Job Description:

PQE is a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With a network of more than 1400 consultants, PQE delivers the highest level of expertise to Life Science customers worldwide and has successfully completed 12,000+ projects for 1,400+ clients. An international group, PQE operates in over forty countries throughout Europe, Asia, and the Americas. PQE offers worldwide coverage with offices and representatives across Europe, North America, Asia, the Middle East, and Latin America, in order to better serve these specific local markets. Further information can be found at www.pqegroup.com.PQE is looking for QC/Micro Lab Equipment Commissioning & Qualification, and related Computerized Control Systems Validation EngineersWorking location: Home office (1/3) + on-site in Morrisville, NC (2/3)Length: 12-14 months (tbc with client)Responsibilities

  • Executes protocols to support purchased vendor protocols of analytical laboratory equipment handling failures to meet tests acceptance criteria, list of equipment include:
  • Microscopes with attached camera
  • Paxit Imaging Camera System
  • BACT Analytical Instrument
  • Milli-Q Water System
  • Cytospin Centrifuges
  • ELISA plate readers
  • EM plate counters
  • Endosafe PTS
  • Spectrophotometers
  • Viable air samplers
  • Executes CSV protocols for computerized systems controlling process/lab equipment per its intended purpose and in compliance with 21 CFR Part 11 requirements, handling failures to meet tests acceptance criteria
  • Executes Design Qualification Protocols, handling failures to meet tests acceptance criteria
  • Reviews Functional/Design/Technical Specifications packages (MCs, TOPs, etc.) verifying components consistency verse bills of components, drawings and field
  • Executes Design Qualification Protocols documenting specifications/documentation verse reference URS/cGMP requirements gap analysis, recording discrepancies
  • Witnesses FAT/SAT protocols execution sessions making sure punch lists be correctly generated
  • Witnesses vendors/contractors during start-up and commissioning phase
  • Executes Project Manager's and Technical Writers' directions escalating discrepancies/issues
  • Communicates with client Engineering/Validation and Vendors teams, under the terms agreed with Project Manager/Technical WritersRequirements
    • At least1-3 years of experience in EU/US cGMP regulated manufacturing facilities
    • Experience in cGMP biotech and sterile manufacturing processes
    • Consolidated knowledge of C&Q activities/practices and related life cycle documents/protocols for sterile/biotech facilities, equipment, and clean medias/utilities production/storage/distribution systems
    • Experience in cGMP facility/equipment start-up, commissioning, and qualification
    • Familiar with using calibrated test instruments, and thermal validation suites/data loggers utilization and pre/post calibration
    • Bachelor's degree in engineering science, or related
    • Understanding of EU/US cGMP requirements for commissioning, validation, and lifecycle management of GMP equipment and systems
    • Naturally prone to work under good documentation/verification practices
    • Ability to work on multiple tasks simultaneously, and escalate issues
    • Requires interpersonal, verbal communication, and technical writing skills
    • Proficient in written and spoken English mandatory

Keywords: PQE Group, Cary , CQ Lab Validation Engineer, Healthcare , Morrisville, North Carolina

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