Computer System Validation Engineer – Contract – Cranbury, NJ
Join a team where your validation expertise will help safeguard the systems and data that support the development of life‑changing therapies.
Proclinical is seeking a Computer System Validation Engineer to support the validation and compliance of GxP computer systems. This position focuses on applying a risk‑based approach to validation activities while adhering to regulatory standards.
Primary Responsibilities
The successful candidate will collaborate with cross‑functional teams to ensure data integrity and system quality throughout the entire lifecycle.
Skills & Requirements
- Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations.
- Direct experience in validating computerized systems.
- Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance.
- Ability to work effectively in a cross‑functional, fast‑paced environment.
- Proven success in implementing data governance measures.
- Strong communication skills, including the ability to present data and visualizations persuasively.
- Preferred experience with UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, and Cell Counters.
- Familiarity with Excel spreadsheet validation.
- Bachelor's degree in Computer Science, Engineering, Biological Science, or a related field.
Responsibilities
- Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training.
- Ensure validation strategies align with Data Integrity principles (ALCOA) and include appropriate testing methodologies.
- Facilitate risk assessments to identify validation deliverables and project requirements.
- Collaborate with Quality Assurance and other teams to optimize operational processes such as change management, backup policies, configuration management, and periodic reviews.
- Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports.
- Analyze validation data and troubleshoot issues in collaboration with technical teams.
- Maintain communication with stakeholders to address system needs, project status, and validation updates.
Compensation
- $100,000 – $125,000 per annum
Contact
Please contact Mike Raletz at
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