Amgen Automation Engineer - AML6 Drug Substance in Juncos, Puerto Rico

SUMMARY

Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment in second shift. Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity. This role is crucial for Amgen's success and it will be a key contributor in the AML 6 Drug Substance organization.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  • Support non-standard shift organization including first, second, night, 12 hours and/or weekends shifts (27/7 operation)

  • Provide solutions to a variety of technical problems of moderate scope and complexity.

  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures.

  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables.

  • Initiate and complete routine technical tasks.

  • Prompt and regular attendance to workplace.

  • Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.

  • Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.

  • Work with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance and/or Validation departments in developing requirements and recommendations for system modifications.

  • Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.

  • Work with consultants, architects and engineering firms on development of standard design documents.

  • Obtain and critique quotes for equipment modifications or installations.

  • Generate rudimentary project cost estimates and schedules.

  • Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).

  • Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.

  • Develop specification, engineering documents, SOP and operating standards.

  • Troubleshoot and resolve equipment, automation or process issues in the field.

  • Operate specialized laboratory equipment and computers as appropriate.

EDUCATION/LICENSES

Master's degree in Engineering

OR

Bachelor's degree in Engineering & 2 years of Engineering and/or Automation experience.

PREFERRED QUALIFICATIONS

  • Educational Background in Mechanical, Electrical, Process Control and/or Chemical Engineering

  • Background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.

  • Working knowledge of pharmaceutical/biotech processes.

  • Familiarity with validation processes and documentation in a highly regulated environment.

  • Strong verbal communication skills in English and Spanish.

  • Comprehensive understanding of validation protocol execution requirements.

  • Skills in the following areas:

  • Problem solving and applied engineering

  • Basic technical report writing

  • Basic technical presentations

  • Personal Organization

  • Validation Protocol Writing

  • Dealing with and managing change

  • Technical (Equipment Specific)

  • Analytical Problem Solving

  • Computer Literacy

  • Knowledge on Rockwell Automation Platform and Allen-Bradley PLCs.

  • Knowledgeable on Rockwell Automation Factory Talk & ControlLogix PLC Platform.

  • Knowledgeable on Rockwell SLC500 PLC families Controllers.

  • Knowledgeable on Rockwell Automation FTView SE and FTBatch systems.

  • Knowledgeable on DeviceNet technologies.

  • Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services.

  • Work schedule flexibility to support 24/7 operations.

  • Knowledge of ASTM 2500, ISA S88 and S95 techniques - Batch processing a desired advantage.

  • Knowledge in programming language (e.g. VBA)

  • Knowledge in Databased SQL programming language

  • ISA Certified Automation Professional

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.Before we had added Master and BS in Mechanical, Electrical, Process Control or Chemical Engineering or related technical field

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.