Role: Validation Engineer (CTMS)
Location: On site in San Carlos, CA or Possible remote for a right candidate
Type: Contract
Length: 6 months to start likely extensions
Description:
We are looking to hire a contract Validation Engineer to help us with enhancements we are conduction through the end of the year on our CTMS. The following scope of services outlines the expected responsibilities and activities to be undertaken by this contract Validation Engineer engaged to support the validation of Client's systems. The selected contractor should have extensive experience in the field, demonstrating a high level of expertise and an ability to manage complex validation tasks autonomously.
Scope of Services:
Validation Documentation Authoring:
- Lead the authoring and execution of validation-related documentation and processes, ensuring compliance with the Client's change control process from initiation to closure.
- Ensure that all validation documentation meets Client's Standard Operating Procedures (SOPs) for documentation and record-keeping, maintaining accuracy within the designated Client's document management system.
Support for System Enhancements:- Provide specialized validation support for Oracle Siebel CTMS enhancements, upgrades, and changes, ensuring alignment with Client's-approved requirements, specifications, and release timelines.
- Utilize extensive experience to proactively identify potential challenges and propose solutions to meet deliverable deadlines.
User Requirements Gathering:- Collaborate with the Client's Global Technology Solutions (GTS) team, business process owners, and key users to gather and document user requirements from Client's stakeholders.
- Lead the drafting of initial requirements and specifications for review, drawing on years of practical experience to guide stakeholder assessments and decisions.
Cross-Functional Team Collaboration:- Manage validation activities across cross-functional teams, ensuring timely execution of validation efforts in compliance with Client's SOPs and quality standards.
- Provide mentorship and guidance to junior validation team members, sharing knowledge and experience to enhance team performance.
Validation Deliverable Collaboration:- Collaborate with Oracle, project stakeholders, CSV QA, and the validation team to author and refine validation deliverables (e.g., Installation Qualification (IQ) documents, Validation Plans, Test Plans, Test Scripts).
- Leverage extensive experience to integrate quality feedback and insights from the Quality team to ensure comprehensive documentation.
Validation Testing Protocols:- Oversee the resolution of validation testing protocols and any discrepancies identified during testing phases.
- Document all outcomes, employing analytical skills derived from years of hands-on experience in validation processes.
Validation Maintenance Activities:- Conduct proactive validation and maintenance activities for assigned Client's systems to ensure compliance with approved specifications, requirements, and internal procedures.
- Adapt and manage validation activities in response to changes in the system, utilizing in-depth knowledge of industry best practices.
Post-Go Live Activities:- Lead post-go live efforts, including the creation and maintenance of user onboarding documentation, assessment of revision release notes for validation impacts, and participation in quarterly system access review documentation.
Compliance and Documentation Management:- Ensure compliance with Client's document and records management procedures.
- Oversee the upload and maintenance of all validation documentation and records on the appropriate Client's platforms.
Contractor Qualifications:- Bachelor's degree in Engineering, Life Sciences, or a related field.
- A minimum of 5-7 years of experience in validation within a clinical or regulated environment.
- Demonstrated expertise in authoring technical and validation documentation in English.
- Familiarity with Oracle Siebel CTMS and validation of clinical systems.
- Strong communication and interpersonal skills, with the ability to effectively engage with various stakeholders.
- Proven ability to be proactive, maintain punctuality with deliverables, and manage multiple tasks independently.
Deliverables:- Complete validation documentation produced and submitted for review as per established timelines.
- Authored validation deliverables, including IQ documents, Validation Plans, Test Plans, and Test Scripts, reflecting high standards of quality.
- Regular updates and comprehensive reports on validation activities, identifying any key issues, resolutions, and progress.
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.