Mfg Systems Engineer

About the role

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Support complex and challenging system automation initiatives that require solid understanding of analytical problem-solving techniques, project management, lifecycle management, and Operational Excellence.
• Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI), and Supervisory Control and Data Acquisition systems (SCADA).
• Support projects focused on improving process equipment/utilities/facilities - from sophisticated unit operation skids to integrating new drug product manufacturing technologies into clinical/commercial facilities.
• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
• Develop detailed specification, engineering documents, SOPs, and computerized system administration job plans.
• Test automation-based process equipment.
• Own and administer process control automation in a GMP regulated manufacturing setting.
• Engage in process change control requests per established SOP and processes.
• Lead technical root cause analysis, incident investigations, and trouble-shooting on process control issues related to mechanical, electrical, instrumentation, and control systems.
• Support a safe working environment by aligning with all pertinent environmental health/safety practices, rules, and regulations.

Requirements

We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is a leader with these qualifications.

• Masters degree OR Bachelors degree and 2 years of Systems Engineering experience OR Associates degree and 6 years of Systems Engineering experience OR High school diploma / GED and 8 years of Systems Engineering experience
• B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering. Strong control system automation background focused specifically in design, installation, programming, and validation of automated processes are essential.
• 2 or more years experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
• Ability to create, update, and read electrical design packages including Software design specifications, URS, among other engineering and validation documentation.
• Strong leadership, technical writing, and communication/presentation skills are required.
• Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.

Preferred Qualifications

• Experience with Data Historian.
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
• Experience with change control, nonconformance, corrective and preventative actions, and validation practices.
• Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.

What We Expect Of You

The vital professional we seek is a leader with these qualifications.

• Masters degree OR Bachelors degree and 2 years of Systems Engineering experience OR Associates degree and 6 years of Systems Engineering experience OR High school diploma / GED and 8 years of Systems Engineering experience
• B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering. Strong control system automation background focused specifically in design, installation, programming, and validation of automated processes are essential.
• 2 or more years experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
• Ability to create, update, and read electrical design packages including Software design specifications, URS, among other engineering and validation documentation.
• Strong leadership, technical writing, and communication/presentation skills are required.
• Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.

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. 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.