Validation Engineer

Foster City, CA (Onsite)

Long Term Contract

Position Summary:

This position is responsible for qualification/validation of equipment, facilities, cleaning and Laboratory processes consistent with cGLP requirements. This position is also responsible for providing technical expertise in the development, improvement, and troubleshooting of Lab equipment and processes. This position coordinates resources from Engineering, Process Development, Quality Control, and Quality Assurance assigned to validation/technical services projects.

Duties and Responsibilities:

• All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Responsible for writing protocols, reports, SOPs, and other formal documents consistent with cGLP requirements as related to qualification and validation activities.
• Responsible for executing qualification protocols for equipment, utilities, facilities, cleaning, and manufacturing processes with proper documentation as related to qualification and validation activities.
• Responsible for assisting in the review and approval of equipment, facilities and other modifications under change control as related to qualification and validation activities.
• Responsible for remaining current on validation practices in the pharmaceutical industry and provide expert advice on validation requirements to other employees.
• Responsible for providing information to QA and other departments on technical aspects of qualified and validated systems.
• Responsible for participating in the selection and qualification of new equipment.
• Responsible for assisting in the production of worldwide regulatory compliant documentation of validation and representing the department in meetings or inspections by regulatory authorities as needed as related to qualification activities.
• Responsible for performing Annual and Quarterly Periodic Reviews as per Client’s compliance schedule as related to qualification activities.
• Responsible for executing and maintaining all equipment, facilities, and utilities in the compliant state throughout each change and each periodic review as related to qualification activities. Includes all summary reports and periodic review documents that must be drafted for each piece of equipment and utility.
• Responsible for providing technical input for the qualification and validation of laboratory equipment as well as facilities.
• Responsible for providing an internal technical support role in engineering by designing and executing necessary studies to support qualification and validation of equipment and facilities.
• Responsible for assisting with due diligence assessments as client reviews new technologies or products.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Laboratory Practices (cGLP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Qualifications:

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Requires Bachelor’s Degree in Science/Engineering and a minimum of 5 years relevant progressive experience in a cGLP environment.
• Requires experience with and an in-depth knowledge of cGLP and cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience in validation and technical services within a pharmaceutical environment.

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.