Randstad Life Sciences US · 1 day ago
Computerized Systems Validation Engineer
Massachusetts, United States
Part-time
Remote
Mid Level
$100K/yr - $100K/yr
4+ years exp
Maximize your interview chancesPharmaceutical Manufacturing
Hiring Manager
Ash Hussin, J.D.
Insider Connection @Randstad Life Sciences US
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Responsibilities
Determine the appropriate validation levels for R&D systems and oversee CSV deliverables.
Collaborate with R&D IT Business Partners on system implementation and upgrades.
Review and approve CSV documentation, including validation plans, specifications, and user acceptance testing.
Approve changes to GxP R&D systems to ensure ongoing compliance.
Support the planning and execution of CSV-related audits for internal systems and service providers.
Oversee audit activities and corrective/preventive actions, collaborating with R&D and IT stakeholders.
Contribute to CSV program management and advise stakeholders on compliance standards.
Assist in Quality and Service Level Agreements with external and internal parties.
Deliver training on compliance topics, 21 CFR Part 11, and SDLC best practices.
Support strategies for regulatory inspections for GCP, GVP, and other compliance areas.
Aid in hosting regulatory inspections and support Quality Operations as needed.
Qualification
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Required
Experience in GxP Compliance
Extensive knowledge of GxP regulations, particularly GCP (Good Clinical Practice) and PV (Pharmacovigilance), with a solid understanding of quality processes, deviations, CAPAs, and quality events.
Familiarity with compliance requirements for regulated systems, including CTMS and safety databases.
Strong understanding of SOPs and the compliance lifecycle for GxP systems, ensuring all implementations follow standard operating procedures and regulatory compliance guidelines.
Proven ability to quickly understand project requirements, apply SOPs, and manage compliance activities effectively.
Experience with global supplier and vendor software audits, ideally with knowledge of regulatory standards from global agencies.
Background in conducting or supporting external audits, gap assessments, and inspections, with an emphasis on continuous quality improvement.
Bachelor’s degree, preferably in life sciences; Master’s degree in a scientific discipline is a plus.
Minimum of 4 years of experience in the pharmaceutical industry, with 3+ years in validation or audit program management.
Strong background in quality assurance, compliance, and CSV, ideally within clinical or non-clinical pharmaceutical R&D.
In-depth knowledge of 21 CFR Part 11, EC Annex 11, GAMP 5, and GxP (GCP, GLP, GVP, GDP) regulations.
Demonstrated ability to lead and motivate with a collaborative approach to complex problem-solving.
Strong decision-making skills with the ability to think strategically.
Proficient in technical writing for SOPs, quality documents, and audit reports with attention to detail.
Strong command of MS Office applications, including Word, Excel, PowerPoint, SharePoint, and Outlook.
Ability to handle complex issues across IT and R&D functions and make sound decisions with a strategic mindset.
Problem-solving skills with solid judgment to identify when to escalate issues.
Preferred
Familiarity with drug development and regulatory affairs processes is advantageous.
Company
Randstad Life Sciences US
Randstad North America, Inc. is a wholly-owned subsidiary of Randstad N.V., the world's largest HR services provider.
Deerfield, IL
1,001-5,000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase
