Senior Manager Process Engineering

Amgen•Holly Springs, NC

4d•Onsite

About The Position

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Requirements

Doctorate degree and 2 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Associate’s degree and 10 years of engineering experience Or High school diploma / GED and 12 years of engineering experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

Bachelor's degree in Chemical or Mechanical Engineering or related technical field.
8+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment focused on process and plant engineering function.
Demonstrated people management/leadership experience.
Direct knowledge of biopharmaceutical production facility with direct experience with Upstream (Seed train, production Bioreactors, Harvest), and Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.
Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
Strong leadership, technical writing, and communication/presentation skills
Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage

Responsibilities

Oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes.
Solve complex engineering problems, optimize processes, and ensure the company's engineering efforts align with strategic objectives.
Provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.
Partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production.
Develop domain expertise to support operations upon start-up, focusing on Process engineering and plant equipment as well as hiring and training the staff required to support startup and operations.
Execute and guide the commissioning and qualification of process equipment in alignment with GMP requirements, while working in partnership with global engineering during site installation.
Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.
Ensure systems are installed, operating safely, and comply with pertinent environmental health/safety practice, rules and regulations.
Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required.
Provide system ownership for process equipment typically used in biologics manufacturing, including Upstream (Seed train, production Bioreactors, Harvest), and Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.
Lead a team of Process Engineering professionals and serve as the main point of contact for Process and equipment engineering function.
Establish clear expectations and priorities to staff.
Encourage a culture of continuous improvement, partnership, and knowledge sharing.
Provide development opportunities, feedback, and actively listen to staff.
Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners).
Work with original equipment manufacturers for breakdown and planned maintenance of process equipment.
Work with integrated service providers for day-to-day operational activities, breakdown and planned maintenance.
Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.
Provide system guidance to identify performance risks and implement risk reduction strategies.
Provide technical support to troubleshoot, identify and resolve process and system issues as needed.
Provide strategic, tactical management, and leadership to ensure 24x7 day-to-day reliability of plant operations.
Participate in the budgeting process for process engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.