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.

All activities are focused on technical and operational support to the production, maintenance, and support staffs in the areas of process improvement, equipment modification and optimization, safety, and quality improvement, and increasing throughput. This is achieved through individual effort and facilitation of teams, tracking, analysis metrics, strong understanding, utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques. 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:

• 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, and componentlayout,,with a goal of designing a process capable of low defects (less than 1%), high uptime (greater than 95%), low waste (less than 1%), and throughput better than estimate

• 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 plant Operations, Maintenance, Quality, Purchasing and Process Engineering

• Prepares SOPs, line layouts, production line diagrams as needed.

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

• Management of the Equipment Acquisition and Installation Process Including:

• Specifies equipment needed, prepares RFQs, and obtains quotes from vendors

• Writes CER’s (Capital Equipment Requests) for new equipment, including researching the justification.

• Manage project budget and timeline

• Negotiate and order equipment when approved

• 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.

• Oversight of determining OQ parameters to start validation

• Approves validation protocols and MPI’s

• Commissioning of equipment including all necessary change controls and training, including leading FAT & SAT activities

• Prepareequipment/engineering estimates for potential projects (to be submitted to sales)

• Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology.

• Research current trends and technologies in packaging; evaluates and test new equipment/processes.

• Coordination of outside design, integration, and equipment manufacturing services.

• Work with staff on the development of new equipment performance requirements.

• Assist Validation with OQ and PQ of new packaging business.

• Write and modify SOPs relating to the production area and assist in the training of affected personnel.

• LeadCAPA investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, poor quality and/or unsafe design.

• Writes and executes engineering protocols as needed.

• UseDOE (Design of experiments) to control variables while testing.

• Apply sound engineering principles to improve existing equipment, packaging design, and processes by reducing waste, increasing throughput, reducing energy consumption, or eliminating human interaction through automation.

• Facilitate cross-functional Lean Six Sigma process improvement teams using a DMAIC method.

• Responsible for the administration, implementation, and project management of new business, including conformance with customer requirements and equipment/process performance criteria.

• Measure and analyze performance metrics of the production area and spearhead initiatives to decrease variability and waste

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Supervisor.

Special Demands:

• 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: Up to 1/4 of the day.

• Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.

• Communicate or exchange information: From 1/2 to 3/4 of the day.

• Detect, distinguish, or determine : From 1/2 to 3/4 of the day.

Qualifications:

Required:

• Bachelor's Degree in engineering or in a related field of study.

• 3+ years related experience and/or training.

• College Level Mathematical Skills

• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.                   

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

• High Standard of Report Writing

Preferred:

• Ability to display excellent time management skills.

• Ability to effectively present information to various people as the job requires.

• Ability to display original thinking and creativity.

• Ability to set and achieve challenging goals.

• Travel as required >10%

#LI-KH1

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, Diversity, Equity, and Inclusion (DEI) 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