Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Lead the design and development of high-speed automated packaging equipment and associated manufacturing systems.
Confer with management, production, and maintenance to analyze technical advancements, process improvements, space requirements, workflow, design layout of equipment and workspace to ensure efficient production methods and positive outcomes.
Participate in the conceptual development of new and or modified production projects and oversee its organization, scheduling, and implementation.
Develop strategic production process documentation to meet anticipated new project requirements in building / equipment / material flow.
Plan and direct the installation, testing, operation, maintenance, and repair of facilities and equipment that are beyond the scope of maintenance utilizing Solid Works or CAD as necessary.
Provide training to Production, Maintenance, and Validations on the operation of new systems.
Manage multiple priorities under tight deadlines and bring assignments to successful completion.
Lead, plan, direct, and coordinate capital budget activities concerned with equipment and new construction.
Ability to manage projects from start to completion, including the collaboration and coordination of resources and departments outside of engineering.
Communication to upper management on status of projects, issue resolution and strategic direction.
Ensure activities are tied to a key process indicator or metric and communicate status, barriers and accomplishments.
Composition of Project documentation to include CAPEX, Project Timelines, and Component Requisitions
Composition of technical documentation including Engineering studies, WI, SOP, FAT, SAT, and URS
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
Bachelor’s Degree in a related field
10+ years of progressive engineering experience, with 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: Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
Supervisory Responsibilities
Ability to Travel
Preferred:
Experience in…