Chemical Process Engineer

CordenPharma

Boulder, CO

Pay: $91,000-$114,000/yr

Shift: Full time

**CordenPharma** is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

**OUR PEOPLE VISION**

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

**SUMMARY**

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Performs research and development activities for the purpose of transferring and designing/improving a process or technology. Provides process engineering support for manufacturing processes in assigned group or plant through developing and implementing continuous improvements. And through troubleshooting methods and equipment used in the production of bulk pharmaceutical intermediates and active pharmaceutical ingredients.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**

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Include the following. Other duties may be assigned.

• Provides day-to-day support for 24/7 manufacturing to assigned processes including support on the manufacturing floor, at times requiring attention outside of the normal work hours
• Evaluates new process fits into manufacturing with supervisory oversight, including consideration of safety, cost, equipment, chemistry, and unit operation technological needs
• With supervisory input, performs process development using process modeling or laboratory scale testing, focusing on critical scale up parameters to transition from kilo-scale to full production scale. Demonstrates and promotes Good Laboratory Practices by maintaining accurate documentation, adhering to laboratory safety procedures, and ensuring compliance with quality standards
• Supports technology transfer between manufacturing sites. Assembles technology transfer packages, develops plans for success, and implements processes into manufacturing with supervisory oversight
• Performs data analysis to identify and implement process improvements and optimizations that reduce costs; improve yields, cycle times, and product quality; mitigate safety, health, and environmental risks; reduce downtime; improve process consistency; and enhance process robustness
• Conducts process troubleshooting and root cause analyses to resolve operational or product issues, supporting deviation closure and Corrective and Preventative Actions (CAPA) development
• Authors and maintains master batch records, ensuring process requirements, equipment configurations, and documentation are accurate, executable, and compliant with quality and regulatory requirements
• Authors process training documentation for operations and provides training for operators
• Supports process validation activities, including authoring protocols and reports, participating in execution activities, and analyzing validation data for assigned process steps
• Monitors manufacturing operations and collects production data to identify anomalies, support real-time issue resolution, evaluate process performance, and author campaign summary reports
• Contributes to Process Safety Management compliance by participating in Process Hazard Analyses, risk assessments, and safety review; providing mass and energy balances; and supplying other engineering data for assigned processes
• Seeks to enhance professional skills through on-the-job training, attending lectures, active participation in professional organizations, and attending formal training courses and conferences
• Supports change control activities by evaluating proposed process, equipment, or procedural change and assisting with implementation in accordance with quality systems
• Collaborates with Manufacturing, Quality Assurance, Quality Control, Validation, Engineering, Maintenance, and EHS personnel to support safe, compliant, and efficient process execution

**LEADERSHIP & BUDGET RESPONSIBILITIES**

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As part of a cross functional team, this position is responsible and accountable for addressing Process Engineering requirements for assigned projects.

**SAFETY & ENVIRONMENTAL RESPONSIBILITIES**

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Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

**QUALITY RESPONSIBILITIES**

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Corden Pharma Colorado (CPC) is a m