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Validation Engineer III

Company: AGC Biologics
Location: Boulder
Posted on: April 4, 2021

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com. Summary AGC Biologics is seeking an energetic and enthusiastic individual with a strong background in Validation or Engineering in biotechnology and/ or pharmaceutical manufacturing to join the Validation Team within the Quality Group. This position will primarily contribute to the cleaning validation and monitoring program including responsibility for the Cleaning Validation Master Plan, validation of CIP, SIP, COP and Autoclave cycles. The position will also contribute the preparation, execution and reporting for validation protocols and provide oversight of protocol executions. PRINCIPAL Responsibilities --- Generation of the cleaning validation master plan, develops cleaning validation program SOPs, protocols and reports--- Develops risk based and worst case cleaning validation strategies using grouping and matrix approaches based on risk--- Manages the cleaning validation and cleaning monitoring programs--- Performs cleaning risk assessment evaluating the introduction of new products determining what cleaning validation or verification activities are required--- Participates in the development of cleaning cycles and procedures--- Apply validation/engineering concepts and company procedures to generate and execute validation protocols and reports--- Execute sampling, cleaning and equipment qualification protocols--- Investigate, resolve and close deviations and associated CAPAs--- Provides technical review of validation deliverables--- Perform qualification and validation protocol development, execution, review and oversight for various production and utility systemsKnowledge, Skills & Abilities --- Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reports--- Must be capable of taking cleaning validation samples, defining an equipment grouping strategy and identifying the worst-case correlation between products, cleaning procedures and equipment--- Knowledge of system validation "life-cycle" concept--- Capable of independent planning/organization/execution of personal workload--- Ability to manage multiple simultaneous projects and deadlines--- Must have excellent written communication skills to develop and write protocols and summary reports--- Must be capable of effectively presenting information to managers and coworkersApplicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply. Education/Experience --- Bachelor's degree in Life Sciences, Engineering, or related discipline with 5+ years of experience--- Previous experience in a regulated pharmaceutical/biologics manufacturing environment is a plusCompensation Range $85,070 - $108,040 annually AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Keywords: AGC Biologics, Boulder , Validation Engineer III, Engineering , Boulder, Colorado

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