Process Engineer - Solution Prep, Upstream, and Downstream

BioSpace; Holly Springs (NC); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Amgen is seeking a Process Engineer to join the Facilities & Engineering group in North Carolina. You will design, qualify, and start up systems for drug substance production, ensuring GMP compliance and operational readiness.

The role involves collaboration with regulatory inspectors, risk assessment, and implementing improvements. You will contribute to site readiness, qualification activities, and 24/7 plant reliability, with occasional travel to support global manufacturing operations.

Qualifications

• Masters degree in engineering or equivalent.
• Bachelors degree with 2+ years engineering experience or higher.
• Associates with 6+ years engineering experience.
• High school diploma with 8+ years engineering experience.

Responsabilités

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support site readiness and startup activities to ensure GMP compliance.
• Coordinate with regulatory inspectors and ensure systems operate safely and in compliance.
• Develop maintenance programs and provide 24x7 on-call and travel support as needed.
• Assist with capital projects and ensure alignment with GMP requirements.

Connaissances

Engineering problem solving

Data-driven analysis

Leadership & communication

Team collaboration

Regulatory knowledge (cGMP)

Formation

Masters degree in Engineering

Bachelors degree + 2 years engineering experience

Associates degree + 6 years engineering experience

High school diploma / GED + 8 years engineering experience

Description du poste

Join Amgens 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 disposable 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.

ProcessEngineer-Solution Prep, Upstream, and Downstream

What you will do

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing domain expertise to support operations upon start-up.

Site Design, Construction, Start-up, And Operational Readiness

• Support the commissioning and qualification of manufacturing systems in alignment with GMP requirements and interact with regulatory inspectors.
• Ensuresystemsare installed and operates safely and comply with pertinent environmental health/safety practice, rules and regulations.
• Support commissioning and qualification of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulations.
• Interact with regulatory inspectors as a manufacturing systems owner to communicate and demonstrate appropriate regulatory compliance of operating systems.
• Assist with new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.

Site Operations

• Provide system support for biopharmaceutical process equipment.
• Assist in identifying and implementing engineering-based improvements or upgrades to equipment or facility systems.
• Support the development of business cases for improvements, identification of design requirements, and translation of these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of improvements.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem solving support to reduce production downtime. This includes supporting technical root cause analysis and implementation of corrective/preventive action.
• Provide rotational on-call support and/or shift support based on business needs to ensure 24x7 day-to-day reliability of Solution Prep, Upstream and Downstream systems for plant operations.
• On-site and up to 10% domestic/international travel.

What we expect of you

Basic Qualifications

• Masters degree
• OR
• Bachelors degree and 2 years of Engineering experience
• OR
• Associates degree and 6 years of Engineering experience
• OR
• High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications

• Bachelors degree in Chemical or Mechanical Engineering or similar engineer discipline.
• 3+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids 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 afterhours engineering coverage
• Ability for domestic/international travel.

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 will 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.

Additional Information

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.