Senior Automation Engineer - AML6 Operations Support

SUMMARY

The Senior Automation Engineer is an exempt position and will apply the advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. This role is crucial for Amgen's success and it will be a key contributor in the AML 6 Drug Substance non-standard shift operations.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• Application of mature engineering knowledge in planning and conducting projects.
• Prompt and regular attendance to workplace.
• Delegate and manage the project work of others.
• Interacts effectively with variety of communication and working styles.
• Independently determine when additional internal resources are needed to solve problems.
• Handle multiple projects at one time.
• Troubleshoot and resolve equipment, automation or process issues in the field.
• Working closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
• Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.
• Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.
• Design, installation, programming and validation of automated processes is essential.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints. Management of contractors and vendors.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems , Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• Develop of detailed specification, engineering documents, SOP and operating standards.

Basic Education & Experience

• Bachelor's degree in Engineering & 5 years of experience in the Pharmaceutical or Biotechnology industries.

OR

• Master's degree in Engineering & 3 years of experience in the Pharmaceutical or Biotechnology industries.

OR

• Doctorate degree

PREFERRED QUALIFICATIONS

• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• 5+ years of experience in engineering in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.
• Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services.
• Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
• Strong process control systems automation background.
• Experience with Tech Transfer, Process Design, and Commissioning
• Experience with validation and change control methodology
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
• Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
• Excellent written and verbal communication skills and the ability to work with minimum direction.
• Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team based environment.
• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.
• Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture.
• In-depth knowledge on Rockwell Automation Platform and Allen-Bradley PLCs
  • Rockwell Automation Factory Talk & ControlLogix PLC Platform.
  • Rockwell PLC5/SLC500 PLC families Controllers.
  • Rockwell Automation RSView SE and FTBatch systems.
  • DeviceNet technologies.

• In-depth knowledge in programing language (e.g. VBA). In-depth knowledge of validation processes and requirements as applied to new equipment installations
• Familiarity with OSI PI Historian.
• Direct hands on experience with lifecycle management of Rockwell hardware and software infrastructure.
• Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering context.
• Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
• Knowledge of ASTM 2500, ISA S88 and S95 techniques. - Batch processing a desired advantage.
• Work schedule flexibility as required to support 24/7 operations, be able to work on non standard shifts providing engineering coverage.
• Experienced in change control, non-conformance, corrective and preventative actions, and validation practices.
• ISA Certified Automation Professional.
• Working knowledge of pharmaceutical/biotech processes and process equipment.
• Familiarity with validation processes and documentation in a highly regulated environment.
• Ability to interpret and apply GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope.
• Demonstrated skills in the following areas:
  • Problem solving and applied engineering.
  • Basic technical report writing
  • Verbal communication
  • Basic technical presentations
  • Personal Organization
  • Negotiation, persuasion and facilitation
  • Collaboration
  • Project cost development
  • Conflict Resolution
  • Leadership and team building
  • Validation Protocol Writing
  • Dealing with and managing change
  • Technical (Equipment Specific)
  • Analytical Problem Solving
  • Computer Literacy
  • Schedule development
  • Facilitation
  • Basic project management

• Comprehensive understanding of validation protocol execution requirements.
• Specialized equipment/process expertise.
• Ability to independently determine when additional external resources are required to solve problems.
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
• Problem solving skills with the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools.

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 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.