Sr Engineer I- Instrumentation

BioSpace; Holly Springs (NC); Vor Ort; USD 120.000 - 160.000; Vollzeit

Benefits dieser Stelle

Retirement and Savings Plan

Medical, Dental and Vision coverage

Stock-based incentives

Flexible work models where possible

Zusammenfassung

Amgen is seeking a Senior Instrumentation Engineer to own instrumentation and controls for drug substance production. You will design, commission, and qualify systems, partnering with engineers to ensure safe, compliant operations.

The role demands hands-on problem solving, calibration program development, and cross-functional collaboration to support GMP manufacturing. Ideal candidates hold a Bachelor’s in Engineering with strong I&C experience, familiarity with DeltaV/Allen-Bradley, and

Qualifikationen

• Minimum years of engineering/I&C experience required at each education level.
• Knowledge of instrumentation and control systems for biopharmaceuticals is preferred.
• Experience working in GMP biopharmaceutical production environments is a plus.

Aufgaben

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Provide instrumentation and control system ownership and engineering support for startup and operations.
• Lead design and qualification activities for instrumentation and controls.
• Collaborate with automation engineers and maintenance teams to resolve field issues.
• Develop calibration programs and ensure spare parts availability.
• Support 24/7 operations with after-hours coverage as needed.
• Support qualification activities and interact with regulatory inspectors.

Kenntnisse

Engineering/I&C experience

Problem solving

Leadership

Cross-functional collaboration

Communication skills

Ausbildung

Bachelor's degree in Engineering

Master's degree (preferred)

Associates degree (backup)

Doctorate degree (not typical)

Tools

DeltaV

Allen-Bradley PLC

Building Automation Systems

Jobbeschreibung

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

SENIOR INSTRUMENTATION ENGINEER / SYSTEM OWNER- RELIABILITY / INSTRUMENTATION / CONTROLS

What you will do

• Lets do this. Lets change the world. 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
• Associates degree and 8 years of Engineering/I&C experience
• Bachelors degree and 4 years of Engineering/I&C experience
• Masters degree and 2 years of Engineering/I&C experienceDoctorate degree

Preferred Qualifications

• A bachelors 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

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, well 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.

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.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.