Specialist, Computer Systems Validation (Contract)
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POST DATE 7/13/2020
END DATE 7/29/2020
JOB DESCRIPTIONAbout Allogene Therapeutics, Inc:
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 ) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a subject matter expert (SME) to support qualification and validation of analytical instruments and equipment in the quality control laboratory. The incumbent will support the QC Senior Manager, Instrument Qualification Software Validation, in defining requirements for the compliant operation and maintenance of analytical instruments and equipment, partnering with stakeholders to complete qualifications/validations, and facilitate resolution of issues. The role will entail operating in a fast-paced, highly dynamic environment and working with internal and external stakeholders.
This is a 6-month contract opportunity in the QC group. This position may start at South San Francisco and move to Newark, CA when facility is ready for staff.
Duties and Responsibilities:
Author and/or review lifecycle documents for analytical instruments and equipment including operation/maintenance SOPs, administration SOPs, impact assessment, risk assessment, user requirement specifications, functional/configuration specifications, qualification protocols and summary reports, trace matrices.
Set the requirements for the execution of software validation and instrument qualifications per Allogene procedures and regulatory guidelines relevant to electronic record/signature and data integrity.
Review, manage, co-ordinate, and approve vendor IQOQPQ protocols, address exceptions as needed, and review/approve reports in partnership with the different stakeholders.
Provide training for the QC organization with regard to systems applications
Partner with IT to ensure regular data backup and recovery plans are in place for computerized systems.
Supports and troubleshoots complex protocol exceptions related to systems
Supports QC IT operations and oversee updates and maintenance of systems on routine basis
Position Requirements & Experience:
A minimum B.S. degree in a scientific discipline is required
Minimum 6-8 years experience in qualifications/validations of analytical instruments and laboratory equipment in a pharmaceutical or related industry
Extensive experience in computer system validation (CSV)
Sound understanding of regulatory requirements and quality guidelines such as FDA 21 CFR Part 11 and Part 820, USP 1058, GxP, GAMP 5, MHRA Data integrity guidelines, EudraLex volume 4 annex 11
Excellent experience with client-server systems including designing test plans, defining test cases, developing and maintaining test scripts.
Hands on experience in validation of bespoke and off-the-shelf software packages desirable
Experience in qualification and validation of analytical instruments and laboratory equipment
Excellent technical writing, organization skills, ability to multitask and work independently on different projects
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
Candidates must be authorized to work in the U.S
As an equal opportunity employer, Allogene Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law poster.