QC Lab Support Validation Engineer

2022-02-08 09:20:122049-08-27Team Horizon
Job TypeContractor
Start Date
AdvertiserMary King
Job Ref2345
Job Views158
We are seeking applications for an experienced QC Lab Support Validation Engineer for our client, who are a leading biopharmaceutical company based in Athlone. The successful applicant will oversee the routine equipment maintenance and provide Equipment & Instrument Qualification Support to the QC Microbiological and Chemistry laboratories in  Athlone to support the advancement of new QC technologies and facilitate new product introduction
Why you should apply:
  • This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  • Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
  • Manage routine laboratory equipment maintenance, qualification and periodic review
  • Schedule and oversee vendors responsible for lab equipment maintenance/calibration
  • Support troubleshooting of instrumentation/equipment issues in the lab
  • Act as lab systems administrator for all QC Laboratory Systems/equipment
  • Planning and conducting routine calibrations and maintenance of lab equipment where required
  • Support the introduction of new QC equipment requiring the planning, executing and documenting the qualification of new lab equipment in cGMP regulated environment.
  • Generate IQ/OQ & PQ equipment validation protocols and associated reports.
  • Ensuring high cGMP, GLP standards are maintained and adherence to schedules and targets to meet regulatory and business requirements.
  • Evaluate systems/equipment in accordance with cGMPs, Part 11 & other regulatory requirements Generation and resolution of protocol discrepancies and deviations as required.
  • Ensure all equipment related QC Procedures and other GMP documentation are implemented and continuously maintained in a compliant and inspection ready manner.
  • Proactively engage with stakeholders and routinely present project progress updates to senior QC management
What you need to apply:
  • Minimum of 7 years of laboratory experience in a cGMP laboratory and instrument validation experience is desirable
  • Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
  • In depth understanding of current regulatory requirements for cGMP laboratory equipment validation and calibration
  • Excellent technical competency in the field of instrumentation and equipment validation.Skilled in organisation, planning, priority setting and time management.
  • Works in a collaborative manner and is able to develop excellent working relationships with peers. Excellent report writing skills.
  • Takes a structured, analytical approach to problem solving.
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