Grove Technical Resources, INC
Senior Quality Systems Engineer
Grove Technical Resources, INC, Boston, Massachusetts, us, 02298
Senior Recruiting Manager @ Grove Technical Resources, INC | Team Leadership, Recruitment
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.
Seniority level Mid-Senior level
Employment type Contract
Job function Engineering, Quality Assurance, and Management
Industries Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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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.
Seniority level Mid-Senior level
Employment type Contract
Job function Engineering, Quality Assurance, and Management
Industries Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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