Process Engineering Analyst

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.

**This position is a 2/2/3 AM schedule**

Job Summary

PCI is seeking a motivated and detail-oriented Process Engineering Analyst to provide technical leadership in production rooms 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 uptime, mechanically, PLC, optimization, safety, and quality improvement. The Process Engineering Analyst will utilize lean six sigma, and Root Cause Analysis techniques and demonstrate excellent organizational and leadership skills in managing technical support, equipment needs, and line layout.

Essential Duties and Responsibilities:

• Process Adherence: Apply engineering principles to maintaining production lines, ensuring minimal defects (<1%), high uptime (>95%), low waste (<1%), and optimal throughput.
• Mechanical Proficiency: Mechanically inclined with some PLC comprehension able to augment troubleshooting efforts.
• Troubleshooting: Identify, diagnose, and resolve mechanical issues, addressing root causes and implementing corrective actions to prevent recurrence.
• Process Optimization: Collaborate with engineering teams to identify areas for mechanical process improvement, enhance productivity, enhance productivity, and ensure consistent product quality.
• 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.
• Cross-functional Collaboration: Work closely with cross-functional teams, including production, quality control, and
• 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.
• Project Assistance: Assist in the execution of Process Line Trials (PLT’s), Engineering Studies, and Operational and Process Qualifications (OQPQ) exercises.
• 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.

This position may have the following special vision requirements.

☐ Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception

☐ Ability to focus ☒ No Special Vision Requirements  

Qualifications:

Supervisory Responsibilities:

• No supervisory responsibilities

Required:

• Associate or Technical degree in Mechanical, Electrical, Instrumentation Controls, or Packaging Engineering,
• 2-5 years of relevant experience or training.
• Hands-on experience with mechanical equipment maintenance, troubleshooting, and process optimization.
• Strong mechanical aptitude and problem-solving skills.
• Familiarity with equipment used in a manufacturing or CDMO environment (Pharmaceutical/Biotech industries a plus)
• Exc