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Sr. Validation Engineer

Company: IGM Biosciences
Location: Mountain View
Posted on: May 3, 2021

Job Description:

Senior Validation EngineerIGM (Nasdaq: IGMS) is a biotechnology company pioneering the development of engineered IgM antibodies for the treatment of cancer patients. IgM antibodies have inherent properties that we believe may enable them to improve upon the efficacy and safety of IgG antibodies in multiple therapeutic applications.We have created a proprietary IgM antibody technology platform that we believe is particularly well suited for developing T cell engagers, receptor cross-linking agonists and targeted cytokines. Our lead product candidate, IGM-2323, is a bispecific T cell engaging IgM antibody targeting CD20 and CD3, that is currently in a Phase 1 clinical trial for the treatment of relapsed/refractory B cell Non-Hodgkins lymphoma (NHL). Our second product candidate is IGM-8444, an IgM antibody targeting Death Receptor 5 (DR5) for the treatment of patients with solid and hematologic malignancies. Also in our product pipeline is IGM-7354, a bispecific IgM antibody delivering interleukin-15 (IL-15) cytokines to PD-L1 expressing cells for the treatment of patients with solid and hematologic malignancies.The Sr. Validation Engineer will report to the Director of Quality or Associate Director of Quality. This position will support and manage the validated state of a phase 1 GMP facility. This position will conduct and manage validations for equipment, utilities, processes, cleaning, software, and methods.Responsibilities:Independently create validation documentation such as system impact assessments, criticality risk assessments, design qualifications, validation protocols, and validation summary reports with input from system owner and SMEs. Oversee and support any external of vendor contract commissioning and qualification of facilities, utilities, software and equipment. Review commissioning documentations such as turn over packages, SATs, and FATs, for completeness and compliance with vendors protocols. Review qualification/validation documents such as IQ, OQ, and PQ for completeness and compliance with protocols. Create and manage a validation master plan for the facility. Create revalidation schedules using a risk-basked approach for the systems. Manage validation and revalidation timelines for project completion. Understand to escalate potential delays in a timely manner. Collaborate with equipment owners and facilities for commissioning and/or decommissioning equipment or utilities. Evaluate new technologies and make recommendations regarding their use. Support quality systems such as change control, deviations, and CAPAs. Support audits and inspections as an SME for validations.Qualifications:BA or BS degree in an engineering or scientific discipline required, or comparable experience. M.S. in an engineering or scientific discipline is preferred.Prior experience with equipment and software, commissioning, and qualification per ISPE is required.Prior experience with operating a Kaye validator is required.Prior experience with temperature mapping of temperature-controlled storage units is required.Prior experience with cleaning, method, and process validation preferred.At least 5 years of experience in cGMP or cGXP at an operational level supporting manufacturing in a pharmaceutical or biotech environment. Experience with Phase 1, 2, or 3 and/or commercial drug substance/drug product manufacturing is required.Knowledge of pharmaceutical cGMPs (US and EU).Experience in preparation of CMC sections of US or EU regulatory filing is preferred.Must have excellent verbal, written, interpersonal, and organizational and communication skills.We offer a fast-paced, collaborative, team-based and family-like work environment. One of our top priorities is to maintain the health and wellbeing of our employees and their families. To achieve this goal, we are offering robust and comprehensive benefits with a variety of options:Medical, dental and vision insurance. The full premium amount for our employees and their dependents is currently covered by IGMSTD, LTD, Basic Life and AD&D Insurance, Supplemental Life and AD&D Insurance401(k) Plan120 hours of Paid Time Off, 5 sick days per year, 10 holidaysCell phone & internet subsidyEmployee Referral Bonus ProgramAnnual training budget for professional developmentCommuter BenefitAnnual bonus programNew hire stock optionsIGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.SDL2017

Keywords: IGM Biosciences, Mountain View , Sr. Validation Engineer, Other , Mountain View, California

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