Business Applications Associate (Computer Systems Validation) - Flexible, preferred local & hybrid (Bridgewater, NJ) but role will be mostly remote

Orbis Clinical is seeking a Business Applications Associate (Computer Systems Validation) located in Bridgewater, NJ for 12 months.

Job Title: Business Applications Associate (Computer Systems Validation)

Location: Flexible, Preferred local & hybrid (Bridgewater, NJ)

Contract: 12 months

Summary:

Engage on CSV Projects as a key team member and drive CSV deliverables. Provide guidance and support to ensure company computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements

Responsibilities will include, but not necessarily limited to the following: 

• Provide strategic leadership and decision making on CSV strategy using company's risk-based approach.
• Develop CSV strategies for different systems/applications including validation of AI Tools/Applications.
• Provide oversight and manage multiple projects at the same time. Drive CSV deliverables in the projects. 
• Author CSV Documents (Validation Plans and Summary Reports)
• Assist/co-author requirements, UFRS/FRS, IQ, OQ, PQ protocol scripts, specifications, and other validation project deliverables
• Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.)
• Guide project team members on CSV projects ensuring team members follow laid out CSV plans
• Provide real-time oversight and support during test execution and review executed protocols
• Route CSV documents for approval(s) 
• Manage & maintain CSV documents in Veeva
• Train, coach, and mentor GxP system owners.

Skills:

• 5-10+ years’ hands on experience in a validation role with responsibility for computer systems specifically Veeva systems – Veeva Quality, Veeva QMS, Veeva RIMS, and other systems.
• Experience in validation of GAMP Category 5 (custom-built/bespoke) systems.
• Experience with AI Tools/Applications and assessing GxP relevance of the AI use case.
• Solid working knowledge of CSV guidelines and FDA/EU regulations:
• 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.
• Strong technical writing skills for authoring, reviewing and approving validation plans, requirements, testing documents and summary reports.
• Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.
• Strong customer service skills for internal and external customers.
• Ability to multi-task on different projects and prioritize efforts effectively.

Education:

• Bachelor's in Computer Science, Engineering, Life Sciences, or a related field.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $80.00 - $90.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes