Validation Specialist (Contract)

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

About the role:

Allogene is seeking a subject matter expert (SME) to support the qualification and validation of analytical instruments and equipment in QC and Manufacturing. The incumbent will support Validation by performing routine qualification and validation activities, including periodic reviews, to ensure the compliant operation and maintenance of analytical instruments and equipment. This role will partner with key stakeholders to execute qualifications and validations and facilitate the resolution of issues. The position requires operating in a fast-paced, highly dynamic environment and collaborating with both internal and external stakeholders.

This is a 6-month contract opportunity within the Validation group and is based in Newark, CA.

Responsibilities include, but are not limited to:

• Author and/or review periodic reviews for analytical instruments, computerized systems, and equipment across QC and Manufacturing. Apply expertise in qualification and validation to review equipment performance, deviations, CAPAs, maintenance history, and change control records, as well as identifying and documenting risks, trends, and required actions. Collaborate with stakeholders to determine impact and required corrective actions.
• Author and/or review lifecycle documentation for analytical instruments, computerized systems, and equipment, including operation and maintenance SOPs, administration SOPs, impact assessments, risk assessments, user requirement specifications (URS), functional and configuration specifications, qualification protocols and summary reports, and traceability matrices.
• Review, coordinate, manage, and approve vendor IQ/OQ/PQ protocols; address exceptions as needed; and review and approve reports in collaboration with cross-functional stakeholders.
• Support and troubleshoot complex protocol deviations and exceptions related to systems and equipment.

Position Requirements & Experience:

• Bachelor’s degree (B.S.) in a scientific discipline is required.
• 6+ years of experience in qualification and validation of analytical instruments and laboratory equipment within the pharmaceutical or related industry.
• Extensive experience in qualification, validation, and computer system validation (CSV).
• Strong understanding of regulatory requirements and quality guidelines, including FDA 21 CFR Part 11 and Part 820, USP <1058>, GxP, GAMP 5, MHRA Data Integrity Guidelines, and EudraLex Volume 4 Annex 11.
• Proven experience with client-server systems, including designing test plans, defining test cases, and developing and maintaining test scripts.
• Experience in the qualification and validation of analytical instruments and laboratory equipment.
• Excellent technical writing and organizational skills, with the ability to multitask and work independently across multiple projects.
• Strong organizational skills with the ability to prioritize effectively and deliver results within established timelines.
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment. The expected salary range for this role is $70 to $80 per hour. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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