PCI is seeking a motivated and detail-oriented Process Engineer I to provide technical leadership in new product launches and continuous improvement initiatives. The ideal candidate will focus on mitigating packaging issues, optimizing production processes, and supporting operational efficiency. This role will involve providing technical and operational support to production, maintenance, and support teams, particularly in the areas of process improvement, equipment modification, optimization, safety, and quality improvement. The Process Engineer I will utilize lean and six sigma techniques and demonstrate excellent organizational and leadership skills in managing projects, equipment needs, staffing projections, and line layout.

Essential Duties and Responsibilities:

• Engineering Review: Perform engineering reviews for new projects, considering equipment size, capability, and component specifications.
• Process Design: Apply engineering principles to design new production lines, ensuring minimal defects (<1%), high uptime (>95%), low waste (<1%), and optimal throughput.
• Customer & Internal Collaboration: Participate in customer meetings and internal reviews with plant operations, maintenance, quality, and purchasing teams.
• Documentation: Prepare SOPs, line layouts, production diagrams, material flow and other necessary documentation. As well as standard work, work instructions and job aids.
• Project Management: Lead project management for assigned projects using standardized methodologies, ensuring timely and cost-effective delivery.
• Packaging Trends & Research: Research new trends in packaging, evaluating and testing new equipment and processes to drive innovation.
• Cross-functional Collaboration: Work closely with cross-functional teams on new equipment performance requirements and process improvements.
• Continuous Improvement: Lead CAPA investigations, identify root causes for packaging issues, and drive corrective actions to improve throughput and quality.
• Lean Six Sigma Methodology: Utilize DMAIC and other Lean Six Sigma techniques to improve processes, reduce waste, and optimize performance.
• Performance Analysis: Measure, analyze, and lead initiatives to decrease variability and improve performance metrics in the production area.
• Adherence to Compliance: Ensure compliance with PCI, cGMP, and GCP policies and procedures.
• Overtime Flexibility: This role may require overtime and/or weekend work to meet business needs.
• Other Duties: Perform additional duties as assigned by the 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.
• On an average day, the individual can expect to move and/or transport up to 10 pounds
• between 1/2 and 3/4 of the day.

Required:

• Bachelor’s degree in mechanical, chemical, biomedical, packaging engineering, or a related field.
• 1-5 years of relevant experience or training.
• Strong mathematical and computer skills with proficiency in engineering tools.
• Excellent communication, report-writing, and problem-solving skills.
• Ability to interpret complex technical information and apply sound engineering principles.

Preferred:

• Ability to manage time effectively and prioritize tasks.
• Strong presentation skills for varying audiences.
• Creative thinking and innovation in process improvements.
• Ability to set and achieve challenging goals.
• Travel requirement: Less than 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.