QC Laboratory CQV Engineer 1733

What is it like to work at SimoTech? With astrong collaborative teamwork culture based on respect, trust and excellence,we play a critical partnering role to our clients' life-changing supplyofproducts to patients. In return, there is excellent salary, benefits, careerprogression, educational support and much more.

SimoTech is seeking a QC Laboratory CQVEngineer to support a leading pharmaceutical client based in Cork. Thesuccessful candidate will join a LabVantage LIMS implementation project and actas a Business SME for the QC laboratory, working alongside the client's ownBusiness SME. The role will primarily support the qualification of laboratoryequipment and analytical instrumentation and their integration with the LIMS.

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

KeyResponsibilities

• Representthe QC Laboratory as a Business SME in the qualification of laboratoryinstruments and their integration with the LabVantage LIMS.
  
• Reviewingand approving IQ, OQ, and PQ protocols and executed records, and supportingtheir execution.
  
• Coordinatinginstrument vendors, including scheduling site visits around laboratoryavailability, witnessing vendor qualification activities and reviewing vendorqualification packages.
  
• Reviewingand approving computer system validation documentation, includingconfiguration, installation, integration testing and audit trail procedures.
  
• Providinglaboratory workflow input to the LIMS configuration, confirming how instrumentresults, units and methods are transferred.
  
• Coordinatinglaboratory downtime and instrument availability and confirming existinginstrument data is backed up prior to software changes.
  
• Supportingdata migration activities for existing laboratory instruments, includingdefining the data in scope and verifying its completeness and integrityfollowing migration.
  
• Supportingchange controls, deviations, and discrepancies arising from qualificationactivities through to closure.
  
• Reviewingand approving qualification summary reports and lifecycle managementdocumentation.
  
• Participatingin user acceptance testing and supporting the laboratory through go-live andhandover of qualified instruments.
  
• Ensuring compliance with GMP, GDP, and Data Integrity requirementsthroughout all project phases.
  

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 theLife Sciences industry, with a focus onpharmaceutical, biotechnology, or other GMP-regulated environments.
  
• Proven experience with LabVantage or a comparable LIMS is advantageous,particularly hands oninvolvement in instrument integration or a LIMS implementation project
  
• Hands-on experience qualifying QC laboratory equipment and analyticalinstrumentation,
  
• includingreview, approval, and execution support of IQ, OQ, and PQ protocols.
  
• Experience of computer system validation for laboratory instruments orLIMS, and of working with
  
• Working knowledge of GMP, the validation lifecycle, and data integrityrequirements including
  
• audittrail review.
  
• Excellent problem-solving skills, with the ability to diagnose andresolve instrument, LIMS integrationand qualification-related issues under project delivery pressure.
  
• Strong collaboration and communication skills, with the ability to workeffectively within diverse, cross-functional, and multi-disciplinary teams.
  

What SimoTech CanOffer

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