Amgen · 4 months ago
Senior Process Engineer
US - North Carolina - Holly Springs
Full-time
Onsite
Mid, Senior Level
$119K/yr - $148K/yr
4+ years expAmgen is a leading biotechnology company focused on serving patients with serious illnesses. They are seeking a Senior Process Engineer to join their Facilities & Engineering group, responsible for designing, building, and qualifying new equipment and systems for drug substance production while ensuring compliance with GMP requirements.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order
Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations
Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors
System guidance to identify performance risks and implement risk reduction strategies
Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs
Qualification
Required
High school diploma / GED and 10 years of Engineering experience OR
Associate's degree and 8 years of Engineering experience OR
Bachelor's degree and 4 years of Engineering experience OR
Master's degree and 2 years of Engineering experience OR
Doctorate degree
Preferred
Bachelor's degree in Chemical or Mechanical Engineering
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Upstream unit operations
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc
Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
Understanding of safety requirements working in a GMP Biopharmaceutical Production facility
Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decision-making
Strong leadership, technical writing, and communication/presentation skills
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
Ability for domestic/international travel (~10%)
Benefits
Competitive and comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-16
2026-01-16
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