Process Engineer I

PCI Pharma Services•Philadelphia, PA

About The Position

The Process Engineer I provides technical leadership for new product launches and leads continuous improvement activities. The role identifies and mitigates packaging issues for existing business using engineering and process improvement methods. It supports production, maintenance, and other staff through process improvement, equipment modification and optimization, safety and quality improvements, and increased throughput. The engineer tracks and analyzes metrics and manages projects, applying good engineering practices and Lean Six Sigma techniques. The role also plans staffing projections, equipment needs and purchases, equipment installation, component layouts, and production line layouts. The position works with customers and internal teams on new products and orders, plans and commissions equipment and tooling, supports validations, and develops or updates SOPs, protocols, and training. It leads or participates in project management, troubleshooting, CAPA investigations, and process improvement initiatives. The position may require overtime and/or weekend work, and travel as required is less than 10%.

Requirements

Bachelor’s degree in mechanical engineering, packaging engineering, or a related field.
1–5 years of related experience and/or training.
College-level mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and use various computer programs.
Full professional proficiency in speaking, reading, and writing for professional needs.
Very high reasoning ability, including defining problems, collecting data, establishing facts, drawing valid conclusions, interpreting technical instructions in mathematical or diagram form, and handling abstract and concrete variables.
High standard of report writing.

Nice To Haves

Excellent time-management skills.
Ability to effectively present information to different audiences as required by the job.
Original thinking and creativity.
Ability to set and achieve challenging goals.
Willingness to travel as required; travel is less than 10%.

Responsibilities

Analyze sales requests to determine the equipment, tooling, or delivery systems needed.
Review components for new jobs, including size, equipment capability, and bar codes.
Design production lines and component layouts to target low defects, high uptime, low waste, and throughput above estimates.
Conduct or participate in customer meetings and attend occasional off-site meetings.
Work with Sales and customers to determine requirements for new products and orders.
Participate in internal planning meetings with Plant Operations, Maintenance, Quality, Purchasing, and Process Engineering.
Prepare SOPs, line layouts, and production line diagrams as needed.
Specify, order, and commission tooling for launch activities.
Specify needed equipment, prepare RFQs, and obtain vendor quotes.
Determine OQ parameters for validation and approve validation protocols and MPIs.
Commission equipment, manage change controls and training, and lead FAT and SAT activities.
Administer, implement, and project-manage assigned projects using standardized methodology.
Research packaging trends and technologies and evaluate and test equipment and processes.
Coordinate outside design, integration, and equipment manufacturing services.
Work with staff to develop performance requirements for new equipment.
Assist Validation with OQ and PQ of new packaging business.
Write and modify production-area SOPs and assist with training affected personnel.
Lead CAPA investigations and actions; initiate investigations and troubleshoot packaging problems and causes of non-conformance.
Write and execute engineering protocols as needed.
Use design of experiments (DOE) to control variables during testing.
Improve existing equipment, packaging designs, and processes by reducing waste and energy consumption, increasing throughput, or eliminating human interaction through automation.
Facilitate cross-functional Lean Six Sigma process-improvement teams using the DMAIC method.
Manage new-business projects to meet customer requirements and equipment and process performance criteria.
Measure and analyze production-area performance metrics and lead initiatives to decrease variability and waste.
Follow PCI, cGMP, and GCP policies, procedures, and rules; maintain required attendance.
Perform other duties as assigned by the Manager/Supervisor.