Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screening.
*Hybrid Role must be local to Northern KY/Cincinnati area
Summarized Purpose:
The Business Systems and Validation Analyst III will serve as a key member of a global Instrument Validation team responsible for validating laboratory instrumentation and computerized systems in accordance with regulatory expectations, including European Medicines Agency (EMA) guidelines and internal quality standards. This role provides advanced business and system support for laboratory software systems and instrumentation, including requirements gathering, SDLC documentation development, validation execution, audit support, risk assessments, and support for system implementations and lifecycle management activities.
This position will play a critical role in supporting regulatory compliance initiatives, client and regulatory inspections, process optimization efforts, and operational standardization activities across multiple laboratory business units. The individual will collaborate closely with laboratory operations, Quality Assurance, Information Technology, vendors, and cross-functional business partners to support compliant software management practices and drive continuous improvement initiatives.
In addition to core validation responsibilities, this senior-level role will provide guidance and mentorship to junior team members, support audit readiness activities, contribute to SOP and process updates, and help drive strategic improvements to the instrument validation program.
- 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.
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- 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.
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.
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