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.