Process Engineer I

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.

Job Summary

We are looking for a dedicated process engineer to provide technical leadership for new product launches and lead continuous improvement activities. You will also identify and mitigate packaging issues for existing business through strong engineering and process improvement methods.

All activities are focused around technical and operational support to production, maintenance, and support staff to include but not limited to: process improvement, equipment modification, optimization, safety, quality improvement, and increasing throughput. The process engineer will achieve this through delivery of tracking, analysis of metrics and project management. The ideal candidate will have a strong understanding and utilization of good engineering practices with the usage of lean six sigma techniques. The process engineer will also provide excellent organizational and leadership skills to determine staffing projections, equipment needs, equipment purchase, equipment installation, component layout, and line layout.**This is a second shift position. Hours are: 4pm to 12 Midnight, Monday to Friday**

Essential Duties and Responsibilities:

• Analyzes sales requests to determine equipment, tooling, or delivery systems needed.
• Performs engineering review of all components for new jobs to include size, capability of equipment, and bar codes
• Apply sound engineering principles to design new production lines and component layout, 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 attends occasional off-site meetings.
• Interact with the sales department and customers to determine requirements for new products and orders.
• Participate in internal review meetings to plan new jobs with plant operations, Maintenance, Quality, Purchasing and Process Engineering.
• Prepare SOPs, line layouts, production line diagrams as needed.
• Specify, order, and commission tooling as required for launch activities.
• Specifies equipment needed, prepares RFQs, and obtains quotes from vendors
• Write CER’s (Capital Equipment Requests) for new equipment which includes researching the justification for usage.
• Negotiate and order equipment when approved.
• Writes protocols for URS’ (User Requirement Specifications), FAT’s (Factory Acceptance Tests), & SAT’s (Site Acceptance Tests.
• Determine 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.
• Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology.
• Research new trends and technologies in packaging; evaluates and tests new equipment and processes.
• Coordination of outside design, integration, and equipment manufacturing services.
• Work with staff on 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 training of affected personnel.
• Leads CAPA investigations and actions. Initiate investigation activity and troubleshoot problems in packaging; discovers causes of non-conformance, i.e., slow throughput, inadequate quality and/or unsafe design.
• Writes and executes engineering protocols as needed.
• Use DOE (Design of experiments) to control variables while testing.
• Applies 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.
• Facilitates 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, rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager/Supervisor.

Qualifications:

Required:

• Bachelor's Degree in mechanical, packaging engineering, or in a related field of study.
• 1-5 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>

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.