Process Engineer

Join Knoa Pharma

Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference.

Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder - at no profit.

The Process Engineer provides engineering ownership and technical expertise for packaging equipment, automation systems, human-machine interface (HMI), and serialization solutions used in Oral Solid Dosage (OSD) pharmaceutical manufacturing. This role ensures reliable, compliant, and efficient packaging operations while meeting global serialization and data integrity regulations. The engineer collaborates cross functionally to support daily operations, projects, validation, and continuous improvement initiatives.

• Provide technical support and ownership for OSD packaging equipment, including bottle lines, bundlers, bundler labelers, case packers, labelers, checkweighers, and vision systems.
• Troubleshoot mechanical, electrical, and controls-related issues to minimize downtime and improve line performance.
• Support equipment installation, commissioning, factory acceptance test/site acceptance test (FAT/SAT), and startup activities.

• Support programmable logic controller (PLC), HMI, and supervisory control and data acquisition (SCADA) systems associated with packaging lines.
• Configure and maintain HMI screens, alarms, recipes, and user access levels.
• Troubleshoot controls and automation issues, working closely with maintenance and automation teams.
• Support automation upgrades, obsolescence management, and standardization initiatives.

• Provide engineering support for serialization and aggregation systems to ensure compliance with Drug Supply Chain Security Act (DSCSA).
• Support integration between packaging equipment, vision systems, serialization software, site repositories, and enterprise systems.
• Manage serialization exceptions, rework processes, aggregation hierarchy issues, and data reconciliation.
• Ensure data integrity and secure handling of serialized information.

• Develop, execute, and support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities for packaging equipment, automation systems, and serialization solutions.
• Support change controls, risk assessments, and revalidation activities related to equipment or software changes.
• Ensure validation documentation is accurate, compliant, and inspection-ready.

• Ensure packaging, automation, and serialization activities comply with cGMP, data integrity, and company quality standards.
• Author and review standard operating procedures (SOPs), user requirement specifications (URSs), functional specifications, validation documents, deviations, and corrective and preventative actions (CAPAs).
• Support internal audits, customer audits, and regulatory inspections.

• Identify and implement improvements to packaging line efficiency, automation reliability, HMI usability, and serialization performance.
• Support or lead capital and improvement projects related to packaging equipment, controls, and serialization upgrades.
• Apply lean manufacturing and operational excellence principles.

• Partner with Manufacturing, Quality, Validation, IT/Automation, and Supply Chain teams.
• Provide technical training and support for operators and maintenance personnel.
• Interface with equipment vendors, automation providers, and serialization vendors.

Bachelor's degree in Mechanical, Electrical, Automation, Industrial, or Chemical Engineering, or a related discipline. Associates degree will be considered with appropriate experience.

6-9 years of engineering experience in pharmaceutical packaging operations, preferably in an OSD environment. Hands‑on experience with packaging equipment and line integration.

• Ability to work with and support automation systems, including PLCs and HMIs.
• Ability to support serialization and aggregation systems in regulated environments.
• Knowledge of and ability to work in compliance with cGMP requirements.
• Knowledge of pharmaceutical packaging operations and associated equipment.
• Ability to apply industrial automation concepts, including PLCs and HMIs.
• Working knowledge of…