Senior Manager Process Engineering - Bulk Drug Substance - Downstream

Amgen•Holly Springs, NC

2d•$148,715 - $201,203•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a global biotechnology company with a mission to serve patients living with serious illnesses. The company has pioneered biotech and is focused on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Amgen is building its newest and most advanced drug substance manufacturing plant, the Amgen FleX batch facility, which will combine single-use and traditional stainless steel equipment for operational flexibility. This facility will feature industry 4.0 capabilities and sustainability innovations, aiming for carbon neutrality by 2027. The Senior Manager Process Engineering will be a key part of the Facilities & Engineering (F&E) group, reporting to the F&E Director. This role will collaborate with the corporate engineering team on the design, build, commissioning, and qualification of new equipment and systems for drug substance production. The position requires developing domain expertise to support operations, focusing on process engineering and plant equipment, and hiring/training staff. The role involves site design, construction, start-up, and operational readiness, including commissioning and qualification of process equipment in alignment with GMP requirements, ensuring operational capability, safety, and environmental compliance. It also includes performing engineering assessments, implementing modifications, and supporting engineering runs for new product introductions. For site operations, the role involves system ownership for downstream purification equipment (Chromatography, viral Filtration skids, UFDF) and CIP/SIP Skids. The Senior Manager will lead a team of Process Engineering professionals, foster a culture of continuous improvement, and collaborate with various departments (Manufacturing, Quality, Process Development, Maintenance) and external partners (OEMs, service providers). Responsibilities include developing and implementing engineering improvements, managing maintenance programs, ensuring plant readiness for audits, providing technical support, managing budgets, and leading day-to-day reliability of plant operations. This role requires 10% domestic/international travel.

Requirements

High school diploma / GED and 12 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR Bachelor’s degree and 8 years of engineering experience OR Master’s degree and 6 years of engineering experience OR Doctorate degree and 2 years of engineering experience
A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
Managerial experience may run concurrently with the required technical experience referenced above.

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 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 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.
Hire and train 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 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 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.
Develop 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.