Process 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.

The Process Engineer is responsible for identifying and mitigating packaging issues for existing business through strong engineering and process improvement methods. Provide technical leadership for new product launches. Lead continuous improvement activities. Secondary tasks include specify, purchase, and commission new equipment and manage capital finances. Provide technical support for new business (Sales/Business Development Support). All activities are focused around 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 and analysis metrics, strong understanding and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques. Additionally, the Process Engineer will be responsible determining staffing, equipment needed, equipment purchase, equipment installation, component layout and line layout

Essential Duties and Responsibilities:

· Analyzes sales requests to determine equipment, tooling, or delivery systems needed.

· Performs Engineering review of all components for new jobs (size, capability of equipment, bar codes).

· Applies sound engineering principles to design new equipment, 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

· Conducts and/or participates in customer meetings and attends occasional off-site meetings.

· Interacts with Sales and customers to determine requirements for new products/orders.

· Participates 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

· Responsible for managing project budget and timeline.

· Responsible for determining OQ parameters to start validation.

· Approves validation protocols and MPI’s.

· 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, poor quality and/or unsafe design.

· Writes and executes engineering protocols as needed.

· Uses 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

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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.