Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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 II to lead continuous improvement activities for the site. The Continuous Improvement Engineer II 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 I 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.
- Acts as the primary point of contact for continuous improvement in manufacturing
- Participates in cross-functional Lean Six Sigma process improvement teams using the DMAIC method.
- Prepare process flow maps and value stream maps of operational processes to identify gaps and opportunities.
- 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 business
- Prepare SOPs, line layouts, production line diagrams as needed.
- Write and modify SOPs relating to the production area and assist in training of affected personnel.
- Prepare reports to recommend action based on data.
- Participate in risk assessment activities e.g., FMEA to identify and mitigate process risks
- Applies sound engineering principles to improve existing equipment and processes by reducing waste, increasing throughput, reducing energy consumption, or eliminating human interaction through automation.
- Participate in 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 in continuous improvement and apply them to enhance operations.
- 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.
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 (Industrial, Mechanical, Electrical) or in a related field of study.
- 2-4 years related experience and/or training.
- Demonstrated leadership skills with ability to drive personal accountability within teams
- 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
- Experience in a GMP and/or pharmaceutical environment.
Preferred:
- Six Sigma 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 10%
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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, 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.
Top Skills
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.