Validation Engineer II-IV

Company: AGC Biologics
Location: Seattle
Posted on: January 14, 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. 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 .SUMMARY:AGC Biologics is seeking an energetic and enthusiastic individual with a strong background in Validation or Engineering to join the Validation Team within the Quality Group. This position will primarily contribute to the cleaning validation and cleaning monitoring program. PRINCIPAL Responsibilities:Performs cleaning validation activities associated with the generation of validation master plans, protocols and reports Develops cleaning validation strategies following a matrix approach based on riskEvaluates the introduction of new products to determine if cleaning validation activities are requiredParticipates in the development of cleaning cycles and proceduresApply validation/engineering concepts and company procedures to generate validation protocols and reportsManages the cleaning validation and cleaning monitoring programsFollows URS documents to determine test scripts and acceptance criteriaInvestigate, resolve and close deviations and associated CAPAsProvides technical review of validation deliverablesKNOWLEDGE, SKILLS & ABILITIES:Must be able to generate qualification protocols (IQ, OQ, PQ) and summary reportsMust be capable of taking cleaning validation samples, defining an equipment grouping strategy and identifying the worst-case correlation between products, cleaning procedures and equipmentKnowledge of system validation ---life-cycle--- conceptCapable of independent planning/organization/execution of personal workload.Ability to manage multiple simultaneous projects and deadlinesMust have excellent written communication skills to develop and write technical presentations and documentationMust be capable of effectively presenting information to managers and coworkersEDUCATION/EXPERIENCE:Bachelor---s degree in Life Sciences, Engineering, or related discipline with 5 to 8 years of experiencePrevious experience in a regulated pharmaceutical/biologics environment is a plusAGC 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, Seattle , Validation Engineer II-IV, Other , Seattle, Washington