What are the responsibilities and job description for the IT Contractor, Computer Systems Validation 2061699 position at Stratacuity: Proven Scientific Placement?
Location: Boston, MA (Hybrid)
Focus: Small Molecule
Job Overview: The CSV Contractor manages software validation and regulatory compliance, offering guidance and crafting required documentation to support GxP system changes.
Primary Job Responsibilities:
- Implement compliant CSV documentation aligned with regulatory standards and the company's CSV framework.
- Design and execute validation tests, including planning and case development, ensuring thorough adherence to protocols.
- Conduct risk assessments, manage vendor and change documentation, and ensure GxP system integrity.
- Keep updated with regulatory trends, develop internal SOPs, and support audit and compliance activities.
Primary Job Requirements:
- Bachelor's degree in computer science or biotechnology engineering, with strong collaborative skills.
- Over 10 years of cloud system validation experience, focusing on SaaS in FDA-regulated settings.
- Proficient in SDLC methodologies, IT controls, and authoring validation documents.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
