GCP - Computer System Validation Specialist (12 month limited-term)

Alimentiv

About The Position

Alimentiv is hiring a Computer System Validation (CSV) Specialist for a 12-month limited-term role. The specialist will validate GCP-regulated systems and collaborate with IT, Quality, and business teams to deliver compliant, reliable solutions. The role leads validation activities from planning through execution, supports system quality and integrity, and promotes ongoing compliance with applicable regulations and industry practices. Responsibilities include executing validation activities for computerized systems and software in accordance with GxP, 21 CFR Part 11, and applicable regulatory requirements; preparing and maintaining validation documentation; coordinating testing; managing defects, deviations, and incidents; and facilitating review, approval, execution, and post-execution management of validation and qualification documents. The specialist also trains and supports project teams, advises on change management for validated systems, and stays current with evolving regulations and industry standards.

Requirements

Bachelor's degree in Computer Science, Information Technology, Engineering, Software Development, or a related field with 3–5 years of relevant experience, or an equivalent combination of education and experience.
Experience validating GCP-regulated computerized systems and software.
Strong understanding of quality system principles, including validation, documentation, change control, training, and audit readiness.
Ability to collaborate effectively in cross-functional and matrixed environments and build relationships with internal stakeholders, business partners, and external vendors.
Excellent written and verbal communication skills, including the ability to document, present, and explain technical and compliance-related information.

Nice To Haves

Experience in the pharmaceutical, biotechnology, medical device, or another highly regulated industry.
Experience working within Software Development Lifecycle (SDLC) processes.
Familiarity with automated testing tools and enterprise validation technologies.

Responsibilities

Execute validation activities for computerized systems and software in compliance with GxP, 21 CFR Part 11, and applicable regulatory requirements.
Develop and maintain validation plans, test scripts, traceability matrices, summary reports, and release documentation.
Partner with IT, Quality Assurance, business stakeholders, and external vendors to define validation strategies and support project delivery.
Coordinate validation testing activities and ensure requirements are appropriately tested and documented.
Manage defects, deviations, and incidents identified during testing, including triage, resolution tracking, and closure documentation.
Facilitate the review, approval, execution, and post-execution management of validation and qualification documentation.
Train and support project teams on validation procedures, tools, documentation standards, and best practices.
Provide guidance on change management for validated systems and stay current with regulatory requirements and industry standards.

Benefits

Education Reimbursement program for full-time employees.
Monthly cell phone and remote work allowance, dependent on role eligibility.
One-time office setup allowance for items such as a scanner/printer, extra monitor, or office furniture.
Working while visiting program for up to 4 weeks per year.
Flexible Summer Hours Program from May through September.
Employee referral incentive.
Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment and permanent members after five years.
Optional formal mentorship program.
Country/region annual social events in person.
Leadership development programs for people leaders, according to seniority.
Social committee and other optional initiatives.