Computer Software Validation Specialist

COMPANY DESCRIPTION: 

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here. 

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. 

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. 

For more information, visit www.Synergbiopharma.com

POSITION OVERVIEW

The Computer Software Validation Specialist  is responsible for ensuring that GxP‑regulated software systems comply with FDA 21 CFR Part 11, cGMP, Annex 11, and GAMP 5 while also supporting business process and technology transformation initiatives. This role combines hands‑on computer software validation, documentation, and testing with business analysis, requirements gathering, data architecture support, and cross-functional solution delivery. The ideal candidate has strong technical expertise, deep knowledge of biotech and pharmaceutical business processes, and experience implementing software solutions in regulated environments. CSV experience is absolutely required, with extensive experience in software implementation, testing, and data/architecture workflows strongly preferred.

JOB RESPONSIBILTIES

• Author, review, and approve validation master plans, User Requirements Specifications (URS), Functional Specifications, configuration documents, traceability matrices, and validation summary reports.
• Testing Execution: Develop and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols to ensure systems function as intended.
• Regulatory Compliance: Ensure systems adhere to cGMP, 21 CFR Part 11, Annex 11, and GAMP 5 while maintaining high standards for data integrity.
• Perform risk and impact assessments to determine the appropriate scope of validation for new systems, upgrades, and changes.
• Change Control and Deviations: Manage change control for validated systems, documenting deviations and driving CAPAs to closure.
• Auditing and Support: Act as a subject matter expert during internal and external audits and inspections.
• Collaborate with business users to understand objectives, requirements, and operational needs across key business areas.
• Document business requirements, functional specifications, solution designs, system requirements, and process/data flows.
• Prepare and lead coordination meetings between developers, business stakeholders, and vendors.
• Partner with developers and technical teams to clarify requirements, ensuring solutions meet approved business needs.
• Perform unit and functional testing as needed and coordinate UAT activities. Validate that final solutions meet documented requirements.
• Maintain and manage issue logs; ensure timely prioritization and resolution of critical issues.
• Apply information systems development, implementation, and control practices across various technology environments.
• Stay current on relevant technology trends, best practices, and industry developments.
• Contribute to data flow mapping, system interfaces, and architecture discussions for scalable, compliant system design.

REQUIRED SKILLS AND QUALIFICATIONS

Education:

• Bachelor’s degree in Computer Science, Information Technology, Engineering, Biology, or related field; or equivalent experience.

Experience:

• 2–5+ years of experience in CSV, validation, or quality assurance roles within regulated industries.
• 2–6 years as a technical Business Analyst supporting technology transformation.
• Experience implementing software in GxP environments is required.
• Clinical Trial Management Systems (CTMS) experience is required.
• Familiarity with LIMS, CDS, and related scientific or operational systems; strong understanding of the full SDLC; experience with software implementation, testing, and configuration in regulated settings.
  
  

Technical Knowledge, Skills, Abilities:

• Strong analytical, technical writing, and problem-solving abilities; high attention to detail; ability to collaborate cross-functionally; strong communication and stakeholder engagement skills; proficiency with MS Office and MS Visio.
• Compliance experience is a major plus.
• CSV experience is absolutely required.
• Heavy software implementation experience and data architecture exposure are strongly preferred.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

he expected salary range for this position is $120,000 to $160,000 yearly. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.