Computer System Validation Specialist (CSV)

• Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
• Author validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies).
• Review and (remote) execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.
• Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.
• Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
• Assist investigate and resolve Deviations, CAPA investigations and other potential issues.
• Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
• Available to attend meetings as necessary
• Periodic Review activities
• Ability to manage three to four active projects

• MODA (EM/ES)
• SAP
• ProcessPad
• ASCTrac
• LIMS
• BMRAM
• ELN
• ComplianceWire
• Adobe sign
• ETQ (reliance)
• Waters/Empower
• Rees
• OSI PI
• Softmax Pro
• Protégé
• Unicorn
• Cytoflex
• Lyrics
• BMS
• Jira

• Minimum of +7 years in the FDA regulated industry.
• 5+ years Document Authoring experience,  SOP revisioning experience and re-executing protocols
• Working knowledge of 21 CFR Part 11 and Annex 11.
• Ability to work on multiple concurrent project initiatives.
• Experience in validating Enterprise systems (both on premise and cloud).  Examples are SAP, Empower, Labware, Veeva.
• Worked with different validation models from V-Model to CSA.
• Ability to apply Agile and Waterfall methodology.
• Excellent written and verbal communication skills.
• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
• Strong collaboration with colleagues at all levels.
• Strong customer service and teamwork oriented.
• Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
• Highly flexible, adapting to changes in priorities, requirements and processes is required.

• BS/BA required in a related field.
• 5+ years minimum required relevant experience.

Last updated on Oct 26, 2023