Continuous Improvement Engineer II

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 Continuous Improvement Engineer to lead continuous improvement activities for the site. The Continuous Improvement Engineer will identify and track opportunities, recommend and implement strong technical solutions and robust processes, and evaluate the organizational impact of in-process and completed projects.

All activities are focused on deploying the continuous improvement strategy for the site, which includes but is not limited to process improvements, process optimization, standardization, and implementation of best practices in all areas of the business. The ideal candidate will have a strong understanding of the principles of continuous improvement, lean six sigma techniques, manufacturing processes, and data analysis. The Continuous Improvement Engineer will also provide excellent organizational, communication and leadership skills to manage projects, develop processes, and highlight opportunities.

Essential Duties And Responsibilities

Measure and analyze performance metrics of the production and support operations and spearhead initiatives to decrease variation and waste.Facilitates cross-functional Lean Six Sigma process improvement teams using the DMAIC method.Prepare process flow maps of critical business and operational processes to identify gaps and opportunities.Partner with the site level finance team to document the fiscal impact of solutionsImplement cultural and behavioral changes to build a strong Continuous Improvement culture throughout the organizationCreate a framework for implementing new processes to ensure that they are robust.Identify best practices and deploy them across the business.Develop new and innovative ways to collect, track, and visualize data.Create dashboards and other communication tools to drive alignment across the businessApply sound engineering principles to design a process capable of low defects (less than 1%), high uptime (greater than 95%), low waste (less than 1%)Prepare SOPs, line layouts, production line diagrams as needed.Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology.Write and modify SOPs relating to the production area and assist in training of affected personnel.Writes and executes engineering protocols as needed.Use DOE (Design of experiments) to control variables while testing.Prepare reports to recommend action based on data.Participate in risk assessment activities e.g., FMEA to identify and mitigate process risksApplies 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.Lead problem-solving and root-cause analysis sessions to drive rapid resolution of safety, quality, or performance events; develop and/or lead actions that will prevent reoccurrence.Stay updated on industry trends, emerging technologies and best practices in pharmaceutical packaging and device assembly and apply them to enhance operations.Stay updated on industry trends in continuous improvement and apply them to enhance operations.This position may require overtime and/or weekend work.Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.Attendance at work is an essential function of this position.Performs other duties as assigned by Manager/Supervisor.

Required

Qualifications

Bachelor’s degree in engineering (Industrial, Mechanical, Electrical) or in a related field of study.3-5 years related experience and/or training.Demonstrated leadership skills with ability to drive personal accountability at every level of the organizationCollege Level Mathematical SkillsIntermediate 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 WritingExperience in a GMP and/or pharmaceutical environment.

Preferred

Six Sigma Black/Green Belt certification.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

EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED

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.