Computer Systems Validation Engineer
Praxis Precision Medicines, Inc. · United States - Remote
Posted 26 days ago
or apply directly on Praxis Precision Medicines, Inc. 's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 26 days Praxis Precision Medicines, Inc. 's roles stay open a median of 42 days
- Reposted
- No
- Salary listed
- No 0% of Praxis Precision Medicines, Inc. 's roles list one
- Ghost-job risk at Praxis Precision Medicines, Inc.
- high 15 stale, 1 reposted of 36 open
- Hiring momentum
- 45 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-09-17
Measured from postings appearing on and disappearing from Praxis Precision Medicines, Inc. 's own greenhouse board since 2026-08-03. Full hiring picture for Praxis Precision Medicines, Inc. .
About this role
The Computer Systems Validation Engineer at Praxis will lead the validation strategy for their GxP technology portfolio, focusing on developing and scaling the Computer System Validation (CSV) capabilities. This role involves collaborating with various teams to ensure compliance and data integrity while implementing risk-based validation approaches. Responsibilities include authoring validation documents, executing testing, and mentoring team members as the organization grows.
- benefits
- 4/5
- freshness
- 4/5
- career value
- 5/5
- role clarity
- 5/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Praxis Precision Medicines, Inc. as an employer.
What you need
- Bachelor's degree in engineering, computer science, information systems, life sciences, or a related discipline; equivalent relevant experience may be considered
- Significant experience working in biotechnology, pharmaceutical, medical device, healthcare, or another regulated environment
- Strong experience with Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles
- Demonstrated ability to lead validation activities across multiple computerized systems and projects
- Experience supporting regulatory inspections, audits, validation assessments, and quality-system documentation
- Strong knowledge of GxP requirements, GAMP 5 and risk-based CSV/CSA principles, 21 CFR Part 11 and EU Annex 11, ALCOA+ data integrity principles
Nice to have
- Familiarity with scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools
What you get
- 99% of the premium paid for medical, dental and vision plans
- Company-paid life insurance, AD&D, disability benefits, and voluntary plans
- 401(k) match dollar-for-dollar up to 6% on eligible contributions
- Long-term stock incentives and Employee Stock Purchase Plan (ESPP)
- Discretionary quarterly bonus
- Flexible wellness benefit
Worth weighing
- Remote position with required travel
- Role involves significant leadership and strategic responsibilities
- Focus on building and developing a team as the organization grows
Summarised from Praxis Precision Medicines, Inc. 's posting. Read the full original.
Listed by Praxis Precision Medicines, Inc. on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
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