Senior Validation Engineer

Career Category Engineering Job Description Join Amgen’s Mission of Serving Patients At 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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. What you will do: Site Aseptic Validation Sr. Engineer - VPHP The validation department performs sterilisation validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing. An exciting opportunity has arisen for a Sr. Engineer in the isolator VPHP (re)-qualification Validation team within the Aseptic Validation team. The Aseptic Validation team perform validation & re-qualification on equipment such as VPHP isolators, autoclaves, CIP/SIP systems and Lyophilisers across our three manufacturing sites (which will soon be expanding) and support labs. The team provides validation oversight for the maintenance and optimisation of critical equipment. The activities of the Site Aseptic Validation Sr. Engineer- VPHP · Support Operations from a Validation perspective to deliver and maintain equipment in a qualified state in the most efficient manner possible. Ensure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation network. · Develop and ensure internal policies, procedures and practices associated with maintenance of the Site Validation Master Plan and Requalification Plans specific to area of responsibility. · Responsible for managing and co-ordinating the VPHP re-qualification program, including scheduling, protocol and summary report review. · Collate and report on relevant validation data and metrics. · Provide validation support for Amgen’s quality management system, including change control, deviation and CAPA processes, providing SME input from a decontamination / aseptic control point of view. · Participate and deliver regulatory filings and RTQ’s for validation. · Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycle process. · Work on moderately complex to complex problems, where analysis of situations or data requires in-depth evaluation of various factors. Strong judgment is required in resolving problems and making recommendations. · Writes and/or implements, owns and approves changes to controlled documents (e.g., SOPs, Specifications, Master Protocols, etc.) as needed. · Support senior leadership in creating and implementing mid to long- term plans for department. · Demonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels. · Ensure projects and routine work are executed safely, efficiently, and in accordance with all applicable codes and Amgen Standards. · Review and approves protocols, reports and data tables generated by staff and contract personnel. On occasion, the Snr Validation Engineer may be needed to support other areas of the team, such as Aseptic Process Simulations, HVAC qualifications, steam sterilisation qualifications. What we expect of you: Basic Qualifications: · Master’s degree with 5+ years of experience in Validation, Engineering, Microbiology or Quality or · Bachelor’s degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality. Preferred Qualifications: · In-depth understanding and application of validation principles, concepts, practices, and standards. · In-depth knowledge of cGxP as well as regulations and compliance requirements for Biologics Drug Product manufacturing. · Extensive working knowledge of sterilisation/decontamination systems, use of biological indicators and industry practices for isolators. · Experience in Aseptic Process Simulations, HVAC and AVS qualifications, and steam sterilisation or depyrogenation qualifications is advantageous, as the Senior Validation Engineer may support these areas. · Demonstrate active listening and provide ongoing feedback within the team, while facilitating problem-solving, decision-making, and issue resolution. · Strong change management skills · Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment · Comfortable in a fast-paced, dynamic, and highly fluid company environment with works under consultative direction toward pre-determined long-range goals and objectives. · Able to adjust workload based upon changing priorities · Make data-driven decisions and communicate ideas and information effectively to Amgen leadership, internal teams, and external partners. · Ability to think critically with demonstrated troubleshooting and analytical skills. What you can expect of us As 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. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation. . Salary Range 74,291.70 EUR - 100,512.30 EUR