Note: The job is a remote job and is open to candidates in USA. Strategic’s life science consulting practice is hiring an Associate Validation Consultant to execute computer system validation and computer software assurance activities under senior consultant guidance. The role supports client validation engagements, maintains validation toolkits, and contributes to Strategic’s Computer Validation as a Service offering.
Responsibilities
- Apply Strategic's validation standards and SOPs in all work, ensuring deliverables align with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles, and escalate questions or gaps to the senior consultant
- Explain the use of Strategic's validation toolkits to clients and deliver validation engagements using them
- Maintain and update Strategic's validation toolkits under the direction of a senior consultant, including updates driven by software releases and changing regulations
- Execute validation test scripts, capture objective evidence in line with ALCOA+ principles, document deviations, and support results review
- Support client validation engagements as embedded staff augmentation, working within client QMS and SDLC constraints under senior oversight; a senior consultant retains client-facing accountability for deliverables
- Follow client SOPs and internal CSV/QMS requirements, and escalate questions, conflicts, or gaps to the senior consultant
- Participate in training and knowledge transfer with senior consultants, and contribute to delivery tasks supporting Strategic's CVaaS (Computer Validation as a Service) offering
Skills
- 1+ year of experience in computer system validation (CSV), computer software assurance (CSA), quality assurance, or a related role in a regulated life science environment
- Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related field (or equivalent experience), plus 1+ year in CSV, CSA, quality assurance, or a related role in a regulated life science environment
- Working knowledge of cGxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+, with a willingness to learn CSA and risk-based validation approaches
- Hands-on ability to execute validation protocols (evidence capture, deviation documentation, results review) and work from standard templates such as URS/FRS, RTMs, IQ/OQ/PQ, risk assessments, and validation summary reports
- Strong technical writing and attention to detail, producing accurate, audit-ready documentation
- Clear communication with QA, IT, and business stakeholders, the ability to adapt to client QMS and SDLC constraints, and the judgment to ask for guidance and escalate issues early
- Responsible use of approved AI and automation tools to improve productivity and quality, in line with company policy and data privacy requirements
- Experience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers, including familiarity with 21 CFR Part 820 / QMSR and ISO 13485
- Prior consulting, staff augmentation, or other client-facing experience
- Industry certifications or coursework such as ISPE GAMP® Essentials, ASQ CQA, CQE, or CPGP
Benefits
- Incentive pay up to 20% of base salary, tied to successful onboarding, training completion, and performance milestones.
- Medical, dental, and vision benefits
- 401(k) with company match
- Paid time off
- Paid holidays
- Company-paid life and AD&D insurance
- Additional voluntary benefits
- Remote work role
Company Overview
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