Computer Systems Validation Specialist

Job Description

• Validation of all laboratory and instrument software including maintenance of the Master Validation Plan, functional requirements, risk assessment and execution of validation protocols
• Data integrity and compliance to 21CFR Part 11 and GxP standards
• Prepare draft and final SOPs and compliance documents
• CCR and validation management
• Validation of spreadsheets and other laboratory working documents
• Review and remediate non-compliance and audit issues
• Liaise with and management activities of laboratory instrument and software vendors
• Develop validation protocols where not provided by vendor
• Troubleshoot and communicate instrument malfunctions
• Review and recommend changes to improve efficiency of automated systems
• Maintain tracking systems for all requests and incidents
• Maintain and manage instrument software versions and releases
• Review and pilot testing of new software and instrument systems as part of system implementations

Qualifications

• Education: Bachelors degree in Science, IT, Engineering or equivalent experience
• Experience: Must have over 2- 5 years of laboratory instrument, laboratory software applications and computer systems validation experience
• Experience should include the pharmaceutical laboratory systems such as Empower and/or Open Lab CDS systems, Agilent, Waters, Thermo Fischer with typical instrumentation such as GC, HPLC, ICP-MS, MS/MS, Spectrophotometers, FTIRs
• LIMS Systems administration and configuration
• Experience in instrument configuration and qualifications in a GxP / biological laboratory environment.
• Working knowledge of GxP regulations and regulatory standards for computer systems validations

Job Type: Contract

Schedule:

• 8 hour shift

Work Location: One location