Senior Manager Process Engineering - Bulk Drug Substance - Downstream

Amgen SA; Holly Springs (NC); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Comprehensive Total Rewards Plans

Job summary

Amgen SA is seeking a Senior Manager in Process Engineering based in Holly Springs, North Carolina. In this critical role, you will oversee the engineering team, guide technical projects, and ensure compliance with GMP regulations.

The ideal candidate will have a strong background in chemical or mechanical engineering, with significant experience in biopharmaceutical operations. You will manage a team, lead daily operations, and implement process improvements.

Qualifications

• 12+ years of engineering experience.
• At least 2 years of experience managing people.
• Experience in biopharmaceutical manufacturing.

Responsibilities

• Oversee engineering team and projects.
• Ensure compliance with GMP regulations and operational readiness.
• Drive process improvements and troubleshooting.

Skills

Leadership

Process Optimization

Project Management

Technical Problem Solving

Education

Bachelor’s degree in Chemical or Mechanical Engineering

Tools

GMP Compliance Systems

Process Equipment

Job description

Senior Manager Process Engineering Downstream

In this vital role, you will oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems, optimize processes, and ensure the company’s engineering efforts align with strategic objectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

Key Responsibilities

• Site design, construction, start-up, and operational readiness
• 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 aligned with manufacturing requirements, GMP regulation, and on‑time project delivery.
• Ensure systems are installed, operating safely, and comply with environmental health, safety practices, rules, and regulations.
• Perform engineering assessments for plant equipment operations, implement equipment modifications, and support engineering runs for new product/technology introductions.
• Site Operations
• 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 functions.
• Establish clear expectations and priorities for staff; encourage a culture of continuous improvement, partnership, and knowledge sharing; provide development opportunities, feedback, and actively listen to staff.
• Collaborate effectively 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 identification and implementation of engineering‑based improvements or upgrades to process equipment systems, including developing business cases, identifying design requirements, and translating requirements into design, specifications, and supporting construction, startup, and validation.
• Develop equipment maintenance programs, ensure availability of spare parts, and coordinate maintenance activities to keep systems in proper working order.
• Ensure plant readiness and quality and regulatory compliance for internal, external agency, and partner audits of 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 24/7 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.
• Travel: 10% domestic/international.

Basic Qualifications

• 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

Additionally, you must have at least 2 years of experience directly managing people and/or leading teams, projects, programs, or directing resource allocation concurrent with the required technical experience.

Preferred Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or related technical field.
• 8+ years of relevant work experience with 5+ years in biopharmaceutical operations/manufacturing focused on process and plant engineering.
• Demonstrated people‑management/leadership experience.
• Direct knowledge of biopharmaceutical production facility 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), interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes (change control, non‑conformances, corrective & preventative actions, qualifications/validation).
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing.
• Independent, ambitious, organized, able to multi‑task in project environments; skilled in communication, facilitation, and teamwork.
• Strong leadership, technical writing, and communication/presentation skills.
• Analytical skills to evaluate and interpret complex problems using multiple sources of information.
• Work schedule flexibility to support 24/7 operations, requiring occasional after‑hours coverage.

What you can expect of us

We support your professional and personal growth and well‑being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.