Description

Responsibilities

• Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
• Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications.
• Validate systems including LIMS, SAP, CMMS/calibration platforms, and other GxP-regulated applications.
• Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews.
• Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles.
• Support audits, inspections, CAPAs, deviations, and remediation activities related to computerized systems.
• Apply GAMP 5 and risk-based validation principles throughout the system lifecycle.
• Support validation activities involving Caliber LIMS, SAP QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable.

Required Qualifications

• 5+ years of Computer System Validation experience within a GxP-regulated environment.
• Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments – REQUIRED.
• Hands-on experience authoring and executing IQ/OQ/PQ protocols.
• Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation.
• Experience validating at least two of the following:
  
  
  
  • Laboratory instruments
  • Manufacturing/engineering equipment
  • LIMS
  • SAP
  • CMMS/calibration systems
• Experience working cross-functionally with Quality, IT, Laboratory, Manufacturing, and technical SMEs.
• Bachelor’s degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience.
• Ability and willingness to work onsite 5 days per week.
• Candidates must be interested and eligible for a contract-to-hire opportunity

Key Skills

Education

Bachelor's degree