Job Description

Validation Engineer

Location: South San Francisco, CA (Hybrid - 3 days a week onsite)

Responsibilities:

• Computer System Validation processes experience
• Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).
• Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
• Experience in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.

Qualifications:

• Bachelor's degree in scientific or engineering discipline along with 5 plus years of experience in the field of computer systems validation.
• Experience in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
• Computer System Validation Engineers must have excellent verbal communication and technical writing skills.
• Experience with all pertinent industry best practices including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
• Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
• Ability to plan and manage own work

Deliverables:

• Ensures validation is being performed per established procedure, review validation documentation, and coordinating between direct groups for the same.
• Communicate to different stakeholders and management on the progress of validation efforts
• Work with project team for identifying the activities of project, dependencies, and figure out future enhancements.
• Execute protocols or peer review protocols depending on the level of access required for execution.
• Support the routing and accurate documentation of all Change Management, Deviation and Corrective Actions Preventative Actions (CAPAs).
• Assist in Performing Risk and Impact assessment for validation activities and change requests.
• Support Data Integrity Assurance Program for all documentation managed by their team.

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.

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