QC Laboratory CQV Engineer 1733

Why SimoTech

What is it like to work at SimoTech? With a
strong collaborative teamwork culture based on respect, trust and excellence,
we play a critical partnering role to our clients’ life-changing supply of
products to patients. In return, there is excellent salary, benefits, career
progression, educational support and much more.  

QC Laboratory CQV Engineer 1733

SimoTech is seeking a QC Laboratory CQV
Engineer to support a leading pharmaceutical client based in Cork. The
successful candidate will join a LabVantage LIMS implementation project and act
as a Business SME for the QC laboratory, working alongside the client's own
Business SME. The role will primarily support the qualification of laboratory
equipment and analytical instrumentation and their integration with the LIMS.

The ideal candidate will have 3+ years of CQV
or validation experience within pharmaceutical, biotechnology, or other
GMP-regulated industry and possess strong laboratory instrument qualification,
troubleshooting, and LIMS experience. This role involves managing multiple
instrument qualification packages and deliverables in parallel while planning
activities around ongoing QC testing.

Key
Responsibilities

• Represent
  the QC Laboratory as a Business SME in the qualification of laboratory
  instruments and their integration with the LabVantage LIMS.
  
• Reviewing
  and approving IQ, OQ, and PQ protocols and executed records, and supporting
  their execution.
  
• Coordinating
  instrument vendors, including scheduling site visits around laboratory
  availability, witnessing vendor qualification activities and reviewing vendor
  qualification packages.
  
• Reviewing
  and approving computer system validation documentation, including
  configuration, installation, integration testing and audit trail procedures.
  
• Providing
  laboratory workflow input to the LIMS configuration, confirming how instrument
  results, units and methods are transferred.
  
• Coordinating
  laboratory downtime and instrument availability and confirming existing
  instrument data is backed up prior to software changes.
  
• Supporting
  data migration activities for existing laboratory instruments, including
  defining the data in scope and verifying its completeness and integrity
  following migration.
  
• Supporting
  change controls, deviations, and discrepancies arising from qualification
  activities through to closure.
  
•  Reviewing
  and approving qualification summary reports and lifecycle management
  documentation.
  
• Participating
  in user acceptance testing and supporting the laboratory through go-live and
  handover of qualified instruments.
  
• Ensuring compliance with GMP, GDP, and Data Integrity requirements
  throughout all project phases.
  
  

Requirements

Key Requirements

• Bachelors or Masters degree in Engineering, Science, Biotechnology,
  Pharmaceutical Sciences, or a related discipline.
  
• 3+ years of CQV, validation, or quality engineering experience in the
  Life Sciences industry, with a focus on
  pharmaceutical, biotechnology, or other GMP-regulated environments.
  
•  Proven experience with LabVantage or a comparable LIMS is advantageous,
  particularly handson
  involvement in instrument integration or a LIMS implementation project
  
• Hands-on experience qualifying QC laboratory equipment and analytical
  instrumentation,
  
• including
  review, approval, and execution support of IQ, OQ, and PQ protocols.
  
• Experience of computer system validation for laboratory instruments or
  LIMS, and of working with
  
• instrument
  vendors on site qualification.
  
• Working knowledge of GMP, the validation lifecycle, and data integrity
  requirements including
  
• audit
  trail review.
  
• Excellent problem-solving skills, with the ability to diagnose and
  resolve instrument, LIMS integration
  and qualification-related issues under project delivery pressure.
  
• Strong collaboration and communication skills, with the ability to work
  effectively within diverse, cross-functional, and multi-disciplinary teams.
  

Benefits

What SimoTech Can
Offer

• Role provides a high degree of autonomy to allow the successful
  candidate to reach their full potential.
  
• Develop new skills and enhance technical ability by working with
  innovative technologies in a multi-disciplined environment.
  
• Opportunity to work with large corporate clients on exciting capital
  projects.