Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
The Automation Engineer (CW) will play a critical role in supporting the design, integration, commissioning,
qualification, validation, and operation of new automated packaging and automated warehouse systems, including ASRS and AGVs.
This role partners closely with Packaging operations, Warehouse, Quality, Technologies/DTI/IT and external
automation vendors to ensure automated systems are designed, implemented, and operated in compliance with
GxP, safety, and quality requirements. The engineer will serve as a technical subject matter expert and contribute to
the development of reliable, scalable, and compliant automation solutions
Support the design, logistics, integration, and operation of automated packaging lines interfacing with the
Automated Warehouse, including Automated Storage and Retrieval Systems (ASRS) and Automated Guided
Vehicles (AGVs).
Support the creation of equipment and systems specifications based on material, compliance and system
operator requirements. Ensure all automation systems meet CGMP, 21 CFR Part 11 and FDA requirements
Lead ASRS, AGVs and Automated Warehouse Compliance documentation
Ensure ASRS/AGV design and operation meet all safety, quality, and regulatory compliance requirements.
Support commissioning, qualification, validation, and operation of new automated packaging lines.
Lead and support the development, testing, implementation, validation, and operation of critical automation
and software systems.
Support Commissioning, Qualification, and Validation (CQV) activities for packaging, ASRS, and AGV systems.
Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT
teams to maintain GxP compliance.
Ensure commissioning and qualification activities align with project requirements, milestones, and schedule
commitments.
Apply engineering principles and practices across automation, controls, robotics, and integrated systems.
Demonstrate a strong understanding of OT/IT convergence, industrial networks, and system integration.
Support and review machine controls design, including PLCs and HMI/SCADA platforms such as AllenBradley, Siemens, RSView, PanelView, and equivalent systems.
Support site computer systems validation (CSV) activities and data integrity requirements.
Work closely with ASRS and AGV vendors/consultants, ensuring contracts, technical specifications, and
deliverables meet Amgen requirements.
Collaborate with users, peers, and management to ensure appropriate standardization and alignment.
Demonstrate the ability to lead cross-functional initiatives and encourage critical, creative problem solving.
Effectively lead and influence teams, achieving both technical outcomes and strong collaboration
Education
Bachelor's or Master's degree in Mechanical, Electrical, Automation Engineering or related discipline
Experience & Requirements
Experience working in an operational GxP-regulated environment with a strong understanding of
applicable regulations and standards
Firsthand experience implementing industrial automation and integrated automation systems
Experience with robotics (ASRS and AGV experience strongly preferred)
Familiarity with Industry 4.0, IIoT, and digital manufacturing technologies
Direct experience working in regulated environments (GMP, OSHA, EPA)
Willingness to travel occasionally, as required; Fluent in English with effective communication skill