Senior Process Engineer - CIP/SIP/Autoclaves

Amgen Inc.; Holly Springs (NC); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen Inc. in Holly Springs, NC seeks a Senior Process Engineer specializing in CIP, SIP, and autoclave systems to partner with Facilities & Engineering for design, build, and qualification of drug substance equipment.

You will own system ownership and provide lifecycle support across commissioning, qualification, startup readiness, and manufacturing operations. The role emphasizes regulatory compliance, collaboration with Manufacturing, Quality, and Process Development, and proactive

Qualifications

• Doctorate degree OR Master’s degree with 2 years of Engineering experience
• Bachelor’s degree with 4 years of Engineering experience OR
• Associate’s degree and 8 years of Engineering experience OR
• High school diploma / GED and 10 years of Engineering experience

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Lead CIP, SIP and autoclave engineering and related equipment.
• Support commissioning, qualification, startup readiness, manufacturing operations.
• Develop maintenance programs and ensure regulatory compliance.
• Collaborate with Manufacturing, Quality, Process Development and maintenance teams.
• On-site travel up to 10% domestically/internationally.

Skills

Leadership

Communication

Project management

Biopharmaceutical operations

Regulatory compliance

Education

Doctorate degree

Master’s degree with 2 years of engineering experience

Bachelor’s degree with 4 years engineering experience

Associate’s degree with 8 years engineering experience

High school diploma / GED with 10 years engineering experience

Job description

Career Category

Engineering

Job Description

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 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.

Senior Process Engineer - CIP/SIP/Autoclave

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. This role will develop domain expertise and system ownership to support process operations, focusing on CIP, SIP and Autoclave engineering and plant equipment.

Demonstrate technical expertise and provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and associated automation platforms. The role will support commissioning, qualification, startup readiness, routine manufacturing operations, troubleshooting, requalification and continuous improvement initiatives with a focus on CIP, SIP and autoclave systems.

Site design, construction, start-up, and operational readiness

Support the design and build of manufacturing equipment systems by aligning design review processes and documents with site requirements, including equipment design and sizing, architecture and electrical distribution, and piping and instrumentation diagrams.

Support factory acceptance testing working in partnership with global engineering during site installation, including reviewing protocols and resolving punch list items.

Work with capital project team to ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations as well as Amgen global engineering requirements. Ensure that systems are installed per the design requirements.

Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providing hypercare support as needed.

Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required.

Site Operations

Responsible system owner for CIP, SIP and Autoclave Drug substance process equipment, areas, and systems providing end-to-end support for operations.

Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.

Work with original equipment manufacturers for breakdown and planned maintenance of process equipment as applicable.

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 master maintenance programs for equipment, 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 technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems.

Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs.

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

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of Engineering experience OR
• Bachelor’s degree and 4 years of Engineering experience OR
• Associate’s degree and 8 years of Engineering experience OR
• High school diploma / GED and 10 years of Engineering experience

Preferred Qualifications

• Degree in Chemical or Mechanical Engineering or similar engineering discipline.
• 6+ years' of relevant work experience with 5+ 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.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• 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
• 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.
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations.
• Ability for limited domestic/international travel.

Salary Range 115,494.60USD -156,257.40 USD