Career CategoryEngineering
Job DescriptionMfg Systems Engineer What you will doLet's do this. Let's change the world. In this vital role as a member of the Amgen Manufacturing & Clinical Supplies - Facilities & Engineering (MCS-F&E) Automation team you will support Clinical & Commercial Drug Product Plant Automation. The successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem solving techniques, project management, lifecycle management and Operational Excellence.
This position requires an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
- Developing 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 -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
- Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Development of detailed specification, engineering documents, SOP and computerized system administration job plans.
- Testing of automation-based process equipment.
- Ownership and administration of 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 practice, rules and regulations
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is a leader with these qualifications.
Basic Qualifications:Master's degree
OR
Bachelor's degree and 2 years of
Systems Engineering experience
OR
Associate's degree and 6 years of
Systems Engineering experience
OR
High school diploma / GED and 8 years of
Systems Engineering experience
Preferred Qualifications:- 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.
- Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
- Working knowledge of Data Historian.
- Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
- Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
- Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
- Individual must be a standout colleague prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
What you can expect of usAs 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'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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn 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.
Application deadlineAmgen 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.
SponsorshipSponsorship for this role is not guaranteed.
