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 transport up to 25 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception

• Ability to focus ☒ No Special Vision Requirements

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled