Full Job Description
Looking for a new challenge with real impact, ensuring technology meets the highest quality and compliance standards in a regulated environment? As a **Computer System Validation (CSV) Specialist**, you will play a key role in validating GCP-regulated systems, partnering with IT, Quality, and business teams to deliver compliant, reliable solutions. You'll lead validation activities from planning through execution, influence system quality and integrity, and help drive continuous compliance with industry regulations and best practices.
**About the Role:**
- Execute validation activities for computerized systems and software in compliance with GxP, 21 CFR Part 11, and applicable regulatory requirements.
- Develop and maintain validation documentation, including 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 ensure successful project delivery.
- Coordinate and oversee validation testing activities, ensuring requirements are appropriately tested and documented.
- Manage defects, deviations, and incidents identified during testing, including triage, resolution tracking, and closure documentation.
- Facilitate 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 ongoing guidance on change management for validated systems and stay current with evolving regulatory requirements and industry standards.
**What we're looking for:**
- **Qualifications**
- Bachelor's degree in Computer Science, Information Technology, Engineering, Software Development, or a related field with **3-5 years of relevant experience**, or equivalent combination of education and experience.
- Experience validating GCP-regulated computerized systems and software, ideally within the pharmaceutical, biotechnology, medical device, or other highly regulated industries.
- Strong understanding of quality system principles, including validation, documentation, change control, training, and audit readiness.
- Proven ability to collaborate effectively in cross-functional and matrixed environments, building strong relationships with internal stakeholders, business partners, and external vendors.
- Excellent written and verbal communication skills, with the ability to clearly document, present, and explain technical and compliance-related information.
- Experience working within Software Development Lifecycle (SDLC) processes; familiarity with automated testing tools and enterprise validation technologies is considered an asset.
**What We Offer**
In addition, as an Alimentiv Employee, you're also eligible for the following programs:
- Education Reimbursement program for full-time employees
- Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
- One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)
- Working while visiting program - up to 4 weeks per year!
- Flexible Summer Hours Program from May - September
- Employee referral incentive - we know great people know other great people, and we think that warrants recognition!
- Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment
- Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!
Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.
**Our Services**
- End-to-end GI clinical trial services, from protocol design through submission support
- Central medical imaging management and endoscopic reading
- Precision medicine and biomarker solutions
- Real-world evidence and clinical consulting
- Histopathology and lab services through AcelaBio
**How to Apply**
To apply for this position, please submit your resume through the Alimentiv Careers Portal or via LinkedIn's Easy Apply. Resumes must be submitted in English.
$69,000 - $115,000 a year
+ Bonus
