Validation Engineer I

Job description

Career CategoryQualityJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. VALIDATION ENGINEER I What you will doLet’s do this. Let’s change the world. In this vital role you will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance. Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment Supply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports) Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met Furnish technical assistance and represent validation for regulatory filings, audits, and inspections Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems Support site/network validation driven continuous improvement initiatives Develop, coordinate, analyze, and present results for operational issues and engineering projects Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment. Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements Communicating with supervisor and support staff, highlighting issues and proposing solutions. Work in a small group of engineers and/or technicians on an ongoing or project basis. Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency. Conduct PQs for parts washers and autoclaves Create / update cleaning process SOPs and / or work instructions Work independently with internal and external stakeholders. Support the development of the periodic cleaning monitoring program Provide engineering support for design, construction, startup, commissioning and qualification. Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity. Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary. Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays) Support investigations of abnormal conditions through Deviation and business processes What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: High school diploma / GED and 8 years of Manufacturing or Operations experience OR Associate’s degree and 6 years of Manufacturing or Operations experience OR Bachelor’s degree and 2 years of Manufacturing or Operations experience OR Master’s degree Preferred Qualifications: Proficient technical writing and presentations skills to collaborate with technical and senior management staff Position requires strong written and verbal skills and the ability to work with minimum direction Experience in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility Proficiency in Kneat, CDOCs, Laboratory Inventory Management System and Pi Proven project management experience – ability to manage multiple priorities Experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC) Knowledge of Regulations Eudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7 Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment. Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information. Ability to function within cross-functional teams and embrace a team-based environment. Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities preferred Familiarity with designing and operating equipment used in biopharmaceutical manufacturing preferred What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a