Overview
Opportunity for an experienced Computer Systems Validation Engineer to support a major QC laboratory systems project at a leading global biopharmaceutical manufacturing site.
This contract role will support the replacement of existing benchtop analytical instruments within the QC laboratory, including commissioning, data migration and qualification activities. The successful candidate will work closely with project, automation, quality and laboratory teams to support compliant delivery of computerized systems and associated validation activities.
Responsibilities
Support replacement of benchtop analytical instruments within the QC laboratory
Prepare qualification deliverables through planning, specification, verification and reporting
Generate and execute test scripts in line with CSV requirements and regulatory expectations
Support commissioning, data migration and qualification activities
Support deviation management and remediation activities
Collaborate with functional teams to support knowledge transfer and robustness of control strategies
Support operational excellence initiatives including 5S, Standard Work, Kaizen and problem solving
Ensure validation activities are aligned with GMP and data integrity expectations
Experience Required
Degree in Engineering or Science related discipline
Minimum 3 years experience in Validation, QA, CQV or Automation
Strong experience in Computer Systems Validation in GMP environments
Experience supporting IQ, OQ and PQ activities
Experience generating or executing validation test scripts
Experience supporting commissioning and qualification activities
Working knowledge of 21 CFR Part 11 and Annex 11
Experience supporting deviations, CAPAs and change controls preferred
Strong communication and cross functional collaboration skills
Preferred Technical Experience
Experience with one or more of the following would be advantageous:
LIMS
Chromatography systems
Benchtop analytical instruments
Laboratory computerized systems
Automation systems
Suitable Backgrounds
Computer Systems Validation Engineer
Validation Engineer
Automation Validation Engineer
Key Focus
This is a hands on execution focused CSV role with emphasis on lab systems, instrument qualification and computerized systems lifecycle support.
#J-18808-Ljbffr