Business Systems and Validation Analyst III

Essential Functions: 

• Gather, analyze, and document business, user, and system requirements for laboratory instrumentation and computerized systems. 
• Lead development, review, and maintenance of SDLC and validation lifecycle documentation including risk assessments, requirements, traceability matrices, and validation reports. 
• Create, execute, review, and manage validation test cases and testing activities for laboratory systems and instrumentation. 
• Support implementation, upgrade, remediation, and lifecycle management activities for laboratory software and instrumentation across multiple laboratory business units. 
• Directly support client, regulatory, and internal audits by representing the instrument validation program, presenting validation documentation, and responding to audit inquiries related to computerized systems, SDLC processes, and compliance controls. 
• Lead process improvement initiatives focused on validation efficiency, standardization, compliance optimization, audit readiness, and risk reduction across laboratory organizations. 
• Author, review, revise, and maintain SOPs, work practices, templates, and process documentation to support evolving regulatory and operational requirements. 
• Provide technical guidance, mentorship, training, and day-to-day support to junior team members related to SDLC processes, validation methodologies, documentation standards, and compliance expectations.
• Collaborate with Quality Assurance, IT, laboratory operations, business stakeholders, and vendors to ensure compliant and effective software management practices. 
• Participate in project planning activities, timeline management, resource coordination, and cross-functional implementation efforts. 
• Support software inventory management, risk assessments, remediation activities, and compliance initiatives for laboratory systems. 
• Identify opportunities for harmonization and standardization of validation processes and documentation across laboratory organizations while accounting for site-specific operational requirements. 
• Utilize and maintain advanced working knowledge of applicable SOPs, regulatory expectations, data integrity principles, and SDLC methodologies. 

Education Requirements: 

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification. 

Experience Requirements: 

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years in a software development, validation, or regulated laboratory environment) or equivalent combination of education, training, and experience. 
• Experience with computerized system validation and SDLC processes within a regulated environment is required. 
• Experience gathering business and system requirements for laboratory software or instrumentation is required. 
• Experience supporting client, regulatory, or internal audits is required. 
• Experience authoring or revising SOPs, work practices, or compliance documentation is preferred. 
• Experience leading or contributing to process improvement initiatives is preferred. 
• Experience mentoring or supporting junior team members is preferred. 
• Experience supporting laboratory instrumentation or laboratory software systems is strongly preferred. 
• Good MS Office skills are required. 

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Knowledge, Skills, and Abilities: 

• Advanced understanding of system development lifecycle (SDLC) methodologies and computerized system validation principles within regulated environments. 
• Strong understanding of regulatory expectations related to data integrity, computerized systems, and laboratory software management. 
• Ability to lead validation activities for moderately complex to complex laboratory systems and instrumentation. 
• Ability to effectively support and participate in client and regulatory inspections. 
• Strong leadership, mentoring, and cross-functional collaboration skills. 
• Proven ability to drive process improvement initiatives and support operational change management activities. 
• Strong technical writing skills with experience authoring and revising SOPs, validation documentation, and compliance-related procedures. 
• Excellent organizational, analytical, problem-solving, interpersonal, and communication skills. 
• Ability to work independently while managing multiple priorities in a fast-paced, regulated environment. 
• Knowledge of clinical trial operations, laboratory workflows, or regulated laboratory environments is preferred. 
• Ability to attain, maintain, and apply advanced working knowledge of applicable SOPs, work practices, process maps, and regulatory expectations. 

Working Conditions and Environment: 

• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. 
• For Labs-based staff, exposure to biological fluids with potential exposure to infectious organisms. 
• For Labs-based staff, personal protective equipment is required such as protective eyewear, garments and gloves. 
•  Exposure to fluctuating and/or extreme temperatures on rare occasions.