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Grove Technical Resources, INC
Computer system validation

Computer system validation

Hybrid

Boston, United states

Freelance

22-10-2025

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Skills

Communication ServiceNow Test Technical Writing Analytical Skills Project Management Agile Analytics

Job Specifications

Job Title: Sr. Quality Engineer – CSA (VMS Site)

Duration: 24 Months

Location: Hybrid (3 days/week in Boston)

Need USC candidates

Note: Parking is the candidate’s responsibility ($3/hr. can be added to pay for parking).

Summary:

Seeking a Senior Quality Engineer experienced in Computer Software Assurance (CSA) and GxP-regulated systems to support Quality Information Systems Management (QISM). The role involves providing Quality oversight across Enterprise, Lab, and Manufacturing systems, ensuring compliance with GMP principles, and driving risk-based validation per GAMP5 standards.

Key Responsibilities:

Provide Quality oversight for systems like ServiceNow, Veeva QMS/EDC, Compass, ERP, RIM, Data Analytics, and Lab/Manufacturing systems.
Apply CSA and GAMP5 principles for validation and lifecycle management.
Review and approve project deliverables (plans, scripts, reports, traceability).
Lead regulatory assessments, change control reviews, and CAPA/deviation handling.
Ensure data integrity, compliance, and effective cross-functional collaboration.
Identify and mitigate quality risks in GMP and GxP environments.

Required Skills & Experience:

Bachelor’s in IT/Computer Science or related field.
5+ years in GMP-regulated computerized systems and CSA/CSV activities.
Strong experience with Lab Quality Systems, GxP compliance, and ITIL/GAMP5 frameworks.
Skilled in validation documentation, test management, and audit readiness.
Excellent communication and analytical skills.

Preferred:

Experience with Veeva Vault QMS, ServiceNow, and ALM (with e-signatures).
Knowledge of Agile validation lifecycle and risk-based validation strategies.
Strong technical writing and project management abilities.

About the Company

Established in 2005, Grove Technical Resources has been at the forefront for providing exceptional services in the medical device industry. As proud members of the Women's Business Enterprise National Council, we prioritize diversity and inclusion to help foster our commitment to being a results-driven company. Our results-driven approach is further exemplified by having received the prestigious "Supplier Excellence Award" from one of the world's largest medical device companies. With extensive experience in various skill s... Know more