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. **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time. + ​​Work is primarily performed at a desk and/or in an office environment.​ for ​​3/4 of the day and up. ​​ The noise level in the work environment is typically, ​moderate. ​ **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 and/or 1-5 years related experience and/or training. + ​​College Level 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. + 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. + Familiarity with general industrial production equipment is a must + Experience with development, modification and approval of package specifications. + Effective at leading project teams and interfacing with customers and operations personnel. + Must be well organized along with being detail and multi-task oriented Preferred: + Ability to identify and resolve problems in a timely manner. + Ability to display excellent time management skills. + Ability to effectively present information to various peopjle as the job requires. + Ability to follow instructions and respond to management direction. + Pharmaceutical and/or food packaging background are highly desired. + Experience with pharmaceutical packaging equipment such as Bio Tech, Blister, Pouch, Bottle, Tablet Feeding, Carton and Carding machinery is highly desirable. + Knowledge and experience in cGMP is desirable. + Knowledge of Lean and / or Six Sigma is a plus + Ability to demonstrate motivational and leadership qualities. \#LI-DT1 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