Sr Engineer I- Instrumentation

Amgen; Holly Springs (NC); Vor Ort; USD 115.000 - 156.000; Vollzeit

Benefits dieser Stelle

Flexible work models

Competitive benefits package

Zusammenfassung

Amgen in North Carolina seeks a skilled Engineer/Instrumentation & Controls professional to design, install, and qualify new process systems for drug substance production. You will lead commissioning, calibration programs, and maintenance planning, aligning with GMP and safety requirements.

The role requires strong problem-solving, data analytics, and collaboration with automation and operations teams, with after-hours support as needed and willingness to travel domestically and internationally.

Qualifikationen

• High school diploma / GED with 10 years of Engineering/I&C experience.
• Associate’s degree with 8 years of Engineering/I&C experience.
• Bachelor’s degree with 4 years of Engineering/I&C experience.
• Master’s degree with 2 years of Engineering/I&C experience.
• Doctorate degree in a relevant field.

Aufgaben

• Design, install, commission, and qualify instrumentation and controls for new/modified systems.
• Provide system ownership for instrumentation and control and support operations.
• Lead or collaborate on calibration programs and spare parts planning.
• Ensure safety, GMP alignment, and regulatory interaction during commissioning.
• Perform root cause analysis and implement corrective/preventive actions.

Kenntnisse

Engineering/I&C experience

Data analytics

Root cause analysis

Six Sigma

Ausbildung

Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering

Master’s degree in related field

Tools

DeltaV

Allen Bradley PLC

Building Automation Systems

Jobbeschreibung

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

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. Additionally, you will develop subject matter expertise to support operations upon start up. Provide system ownership for Instrumentation and Control of equipment, and supporting operations at the site, including manufacturing and lab equipment. Provide engineering support for design, construction, startup, commissioning and qualification of instrumentation and controls for new or modified systems. Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable items. Partner with Automation Engineers, equipment System Owners and maintenance technicians in identifying and solving field communication issues. Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, efficiency, or other unique capabilities to Amgen manufacturing. Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the Instrumentation and Controls or facility systems. Lead the development of a case if required to support the completion of the project. Support development of Calibration programs, ensure the availability of spare parts, and coordinate maintenance plan as vital to ensure systems are in accurate working order. Ensure systems are installed and operating safely and align with pertinent environmental health/safety practice, rules and regulations. Ensure vital commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as vital. Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process instrumentation systems. Monitor systems to identify performance risks and implement risk reduction strategies. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays). Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Advance the use of condition based and predictive maintenance practices by incorporating sophisticated data analytics where applicable. Own investigations of abnormal conditions through Deviation and business processes.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

High school diploma / GED and 10 years of Engineering/I&C experience.
Associate’s degree and 8 years of Engineering/I&C experience.
Bachelor’s degree and 4 years of Engineering/I&C experience.
Master’s degree and 2 years of Engineering/I&C experience.
Doctorate degree

Preferred Qualifications:

A bachelor’s degree in Chemical, Mechanical, or Electrical Engineering.
4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment.
Hands on experience of design and troubleshooting instrumentation and controls for process equipment and utility systems in a GMP Biopharmaceutical Production facility.
Experience with field wiring and communications of field equipment and in relation with process control system such as DeltaV, Allen Bradley PLC and/or Building Automation Systems.
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 carrying out of capital projects.
Understanding of the process 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 collaboration.
Great teammate prepared to work in and adopt a team-based culture that relies on collaboration 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.
The ability and willingness to travel domestic and international.

What you can expect of us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Sponsorship

Sponsorship for this role is not guaranteed.

EEO Statement

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Salary Range

115,494.60USD -156,257.40 USD

Additional Information

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen