Validation Engineer, Automation
Location: Foster City, CA (strictly onsite)
Length: 12 Months + Likely Extensions
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
Other:
Our client requires that all employees be up to date with current Covid vaccine/booster state mandates. 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.