Description
Summary
The Sr. IT Validation Specialist will participate and make a positive difference in a growing, fast-paced clinical stage company. In this role, you will plan, author, implement and maintain computerized system validation for business systems used to support regulated activities (i.e., GxP). The ideal candidate will have enterprise-level, hosted-application validation experience.
The Sr. IT Validation Specialist will collaborate with IT, business function, and Quality staff to develop consistent validation strategies, implement, and improve standards for IT change management and collaborate with the IT leadership to define resource allocation and validation timelines.
Responsibilities
- Gather and documents user requirements from business stakeholders to establish intended use of computerized systems.
- Author validation deliverables in collaborate with project stakeholders to (e.g., IQ, Validation Plan, Test Plan, Test Scripts, etc.)
- Manage validation activities of cross-functional teams to ensure validation effort is executed to plan and properly documented in the appropriate validation documents.
- Execution of validation test protocols (either paper or electronic)
- Support resolution and documentation of protocol and test discrepancies.
- Ensure validated systems remain in compliance with applicable regulations and internal procedures as changes to the systems are made.
- Maintain computerized system validation documentation.
Qualifications
- 3+ years in direct hands-on experience validating GxP Computerized Systems
- Advanced knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAMP
- Experience validating Quality, Regulatory and/or Clinical systems a plus
- Experience validating Veeva Vault applications a plus
- Experience with qualification of IT infrastructure a plus
- Excellent written and oral communication skills.
- Strong planning, organizing, and execution skills.
- Ability to proactively manage workload and meet deadlines.
- Develop and implement creative solutions to improve processes
This role is based at our Hayward facility with an onsite requirement of 2 days. The anticipated salary range for fully qualified candidates applying for this position is $95,000 – $125,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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