Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. This position qualifies and validates analytical instruments used in the Quality Control (QC) laboratory and Manufacturing operations by authoring, executing and preparing qualification protocols and validation final reports. This position also qualifies and validates process equipment used in manufacturing. Specifically the Validation Engineer III will coordinate internal personnel, interface closely with QC and external service providers to schedule, generate, execute, report and provide coordination and oversight of instrument and equipment qualification activities. This role ensures qualification addresses necessary CFR Part 11 computerized systems validation and Data Integrity functionality qualification for compliance with computerized systems validation (CSV) requirements when applicable working with CSV systems validation engineers. This role may support implementation of computerized laboratory information management systems (LIMS) and instrument data management systems (Empower) qualification. This role will participate in internal and external audits, change control assessment, validation deviation investigation and CAPA. The Validation Engineer III also supports customer project and QA Validation teams and evaluation of risk assessments in order to maintain continuous improvement at AGC Biologics. This position requires following procedures, adherence to GMP and GDP principals and requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES Prepares/ executes IQ/OQ/PQ protocols for equipment and analytical instruments including related software and computerized systems to ensure CFR Part 11 and Data Integrity compliance. Identify, investigate, and resolve validation deviations encountered during IQ/OQ/PQ. Plan qualification and validation activities, coordinate cross functional team members and/ or outside service providers and/ or contractors to execute, review and approve validation protocols and reports. Generates and reviews qualification report and helps summarize the results which may be viewed by clients and regulatory agencies. Performs validation periodic review and re-qualification of equipment and analytical instruments. Performs change control validation assessment to determine risk based qualification. requirements for new systems and changes to existing qualified systems. Perform validation activities in accordance with procedures, protocols and GMP requirements. Participate in process and procedure improvement as part of AGC Biologics continuous quality improvement mission. KNOWLEDGE, SKILLS, AND ABILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Knowledge: GMP, IQ/OQ/PQ, Analytical Instrument Qualification, Computerized Systems Validation, Equipment IQ/OQ/PQ Skills: Critical thinking, problem solving skills, experimental design, data evaluation skills. Excellent written communication, protocol and report writing skills, technical writing skills. Attention to detail. Abilities: Team player who is collaborative with a positive attitude. Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated. Strong interpersonal, written/oral communication and problem solving skills EDUCATION and/or EXPERIENCE BA or BS with at least 6 years QA-related validation experience or equivalent work experience or a Master degree in a scientific discipline with at least 4 years related experience; may include equivalent work experience in a cGMP manufacturing facility. Experience with application of validation compliance and principles of quality which drive QA Validation strategy and oversight. Experience in facilitating change control, deviations/investigations, and closure. Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure. Equivalent education and experience may substitute for stated requirements Salary Range: $94,000 - $129,250 Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! 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. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.