PHL_Project Engineer

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.

Summary of Objective:

The project engineer role focuses on technical and operational support for new product inception, new equipment project management, and continuous improvement. Leads the design, installation and start-up of new equipment, equipment tool sets and support new business development/quoting. The project engineer should also have excellent organizational and leadership skills to determine staffing projections, equipment needs, equipment purchase, equipment installation, component layout, and line layout.

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.

The Project Engineer role supports several areas the new product inception process, equipment commissioning process and site continuous improvement.

New Product Inception

• Responsible for the administration, implementation, and project management of new business, including conformance with customer requirements and equipment/process performance criteria.
• Analyze sales requests to determine equipment, tooling, or delivery systems needed.
• Performs engineering review of all components for new jobs to include size, the capability of equipment, and bar codes

• Apply sound engineering principles to design new equipment, production lines, component layouts, and identify staffing requirements.

• Conduct and/or participates in customer meetings and attend occasional off-site meetings.  Interacts with Sales and customers to determine requirements for new products/orders.
• Participate in internal review meetings to plan new jobs with site department leaders.

Project Management

• Management of the Equipment Acquisition, Tooling Purchases and Installation Process for projects for projects up to $200K.
• Writes CER’s (Capital Equipment Requests) for new equipment, including researching the justification.
• Manage project scope definition, project budget, timeline, and deliverables.
• Develop design criteria and equipment specifications, including safety, regulatory and necessary performance criteria
• Writes protocols for URS’ (User Requirement Specifications), FAT’s (Factory Acceptance Tests), & SAT’s (Site Acceptance Tests), and SOP’s (Standard Operating Procedures)
• Lead commissioning of equipment including leading FAT & SAT activities and assist validation with OQ and PQ

• Specify, order, and commission tooling as required for launch activities.

Continuous Improvement

• Support continuous improvement activities to aid with increasing efficiency and reducing waste.
• Facilitate cross-functional Lean Six Sigma process improvement teams using a DMAIC method.

General

• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
• Performs other duties as assigned by Manager/Supervisor.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: From 1/4 to 1/2 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): None.
• Communicate or exchange information: From 1/4 to 1/2 of the day.
• Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transp