Opportunity at
AlimentivGCP - Computer System Validation Specialist (12 month limited-term)
Alimentiv is seeking a Computer System Validation Specialist for a 12-month limited-term, full-time opportunity with a compensation range of USD 69,000 to 115,000 per year. Alimentiv…
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About This Role
Alimentiv is seeking a Computer System Validation Specialist for a 12-month limited-term, full-time opportunity with a compensation range of USD 69,000 to 115,000 per year. Alimentiv operates as a global contract research organization focusing on advancing treatments for gastrointestinal diseases. The company employs roughly 700 individuals internationally across three service lines, channeling commercial success back into scientific research, technology, and staff development. In this role, the selected candidate will take…
Job Description
Alimentiv is seeking a Computer System Validation Specialist for a 12-month limited-term, full-time opportunity with a compensation range of USD 69,000 to 115,000 per year. Alimentiv operates as a global contract research organization focusing on advancing treatments for gastrointestinal diseases. The company employs roughly 700 individuals internationally across three service lines, channeling commercial success back into scientific research, technology, and staff development.
In this role, the selected candidate will take charge of validation activities for computerized systems and software, ensuring adherence to GxP, 21 CFR Part 11, and other regulatory standards. The position requires partnering closely with IT, Quality Assurance, business units, and external vendors to develop validation strategies, manage testing, and handle defects. The ideal professional brings a strong background in validating GCP-regulated systems and maintaining quality documentation within regulated industries.
Responsibilities
- Perform validation procedures for computerized software and systems in alignment with GxP and 21 CFR Part 11 guidelines
- Create and upkeep validation records, such as test scripts, traceability matrices, plans, and summary reports
- Collaborate with IT, Quality Assurance, business stakeholders, and outside vendors to establish validation approaches
- Supervise validation testing to confirm requirements are properly tested and recorded
- Track and resolve defects, deviations, and incidents discovered during testing
- Handle the review, approval, and post-execution management of qualification and validation paperwork
- Educate and assist project teams regarding validation standards, tools, and best practices
- Offer ongoing advice concerning change management for validated systems while keeping up with regulatory changes
Requirements
- Experience validating GCP-regulated computerized systems and software within the pharmaceutical, biotechnology, medical device, or other highly regulated sectors
- Solid understanding of quality system principles covering validation, documentation, change control, training, and audit readiness
- Demonstrated ability to work collaboratively in cross-functional and matrixed organizational environments
- Strong written and verbal communication skills for documenting and explaining technical and compliance details
- Familiarity with Software Development Lifecycle processes
Qualifications
- Bachelor's degree in Computer Science, Information Technology, Engineering, Software Development, or a related discipline, paired with 3-5 years of relevant experience
- Alternative combination of education and equivalent experience
- Familiarity with automated testing tools and enterprise validation technologies
Core Skills
Benefits
- Education Reimbursement program for full-time employees
- Monthly Cell Phone and Remote Work Allowance depending on role eligibility
- One-time office setup allowance
- Working while visiting program allowing up to 4 weeks per year
- Flexible Summer Hours Program from May through September
- Employee referral incentive
- Beneficiary status in the Alimentiv Trust after one year of employment and permanent membership after 5 years
- Optional formal mentorship program known as Alimentorship
- Country and region annual in-person social events
- Leadership development programs for people leaders based on seniority
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the employment type and duration for this role?
This position is a 12-month limited-term, full-time role.
What is the salary range for the Computer System Validation Specialist?
The salary ranges from USD 69,000 to 115,000 per year.
Where is the position located?
The specific location is not stated in the job posting.
How can I apply for this position?
Candidates can apply by submitting a resume in English through the Alimentiv Careers Portal or via LinkedIn's Easy Apply.
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