Sr. Principal Automation & Pharmaceutical Packaging Engineer

PCI Pharma Services•Rockford, IL

About The Position

PCI Pharma Services is hiring a Sr. Principal Automation & Pharmaceutical Packaging Engineer to lead the design, development, integration, and implementation of high-speed automated packaging equipment and related manufacturing systems. The role collaborates with management, production, maintenance, validations, and other departments to improve processes, plan production layouts and workflows, and deliver new or modified production projects from concept through implementation. It also directs installation, testing, operation, maintenance, and repair of facilities and equipment beyond the scope of maintenance, using SolidWorks or CAD as needed. The engineer leads capital budget and new-construction activities, manages multiple projects and priorities, communicates project status and strategic direction to upper management, and ensures work is connected to process indicators or metrics. The role prepares project and technical documentation, including CAPEX plans, timelines, component requisitions, engineering studies, work instructions, SOPs, FATs, SATs, and URSs. It provides training to Production, Maintenance, and Validations on new systems and requires adherence to PCI, cGMP, and GCP policies and procedures. Overtime and/or weekend work may be required.

Requirements

Bachelor’s degree in a related field.
10+ years of progressive engineering experience, including substantial experience designing, developing, integrating, and implementing automated manufacturing equipment.
Extensive experience with high-speed automated equipment, pharmaceutical packaging, inspection systems, or similarly complex regulated manufacturing equipment.
Demonstrated expertise in mechanical machine design and equipment development.
Strong working knowledge of robotics, servo systems, motion control, automation, machine vision, sensors, pneumatics, and integrated manufacturing systems.
Statistical and advanced mathematical skills.
Advanced computer skills, including the ability to perform complex computer tasks and operate various computer programs.
Full professional proficiency in speaking, reading, and writing for professional needs.
Ability to apply logical or scientific principles to a wide range of intellectual and practical problems and work with concrete and abstract variables.
Supervisory responsibilities and ability to travel.
Ability to work overtime and/or weekends when required.
Ability to manage projects, coordinate resources, and communicate project status and issues.

Nice To Haves

Experience in pharmaceutical packaging, pharmaceutical manufacturing, medical device manufacturing, or other highly regulated industries.
Experience with serialization, vision inspection, robotics, high-speed filling or packaging, automated material handling, or integrated production lines.
Experience with PLC/controls architecture and integration with mechanical automation systems.
Experience leading large-scale automation or capital equipment programs.
Ability to present information effectively to different audiences.
Ability to identify and resolve problems in a timely manner.
Demonstrated success managing employees.
Attention to detail.
Ability to provide strategic direction and support independent decision-making by others in the Engineering department.
Ability to set challenging goals and drive accountability and collaboration to achieve them.

Responsibilities

Lead the design and development of high-speed automated packaging equipment and associated manufacturing systems.
Work with management, production, and maintenance to analyze technical advancements, improve processes, assess space requirements and workflow, and design equipment and workspace layouts for efficient production.
Participate in conceptual development of new or modified production projects and oversee their organization, scheduling, and implementation.
Develop strategic production-process documentation to meet anticipated project requirements for buildings, equipment, and material flow.
Plan and direct installation, testing, operation, maintenance, and repair of facilities and equipment beyond the scope of maintenance, using SolidWorks or CAD as necessary.
Train Production, Maintenance, and Validations personnel on operation of new systems.
Manage multiple priorities under tight deadlines and complete assignments successfully.
Lead, plan, direct, and coordinate capital budget activities involving equipment and new construction.
Manage projects from start to completion, collaborating and coordinating resources and departments outside of Engineering.
Communicate project status, issue resolution, and strategic direction to upper management.
Tie activities to key process indicators or metrics and communicate status, barriers, and accomplishments.
Prepare project documentation, including CAPEX, project timelines, and component requisitions.
Prepare technical documentation, including engineering studies, work instructions, SOPs, FATs, SATs, and URSs.
Adhere to PCI, cGMP, and GCP policies, procedures, and rules.
Perform other duties as assigned by the Manager or Supervisor.