Process Engineer

Job Title:

Process Engineer

Job Description

The Process Engineer provides technical support and engineering solutions for process and equipment-related issues in a regulated pharmaceutical and animal health manufacturing environment. This role focuses on ensuring equipment and processes remain in a validated and controlled state, supporting production and maintenance teams, and driving continuous improvement in safety, quality, and efficiency.

Responsibilities

* Provide technical support and engineering solutions for process and equipment-related issues, including real-time support for production staff during manufacturing activities.

* Provide technical support for maintenance activities and assist in troubleshooting complex equipment and process problems.

* Understand the basis for the qualification of equipment and ensure that all equipment and systems remain appropriate and fit for their intended purpose.

* Ensure equipment and processes operate in a consistent and expected state of control, aligned with regulatory commitments, cGMP requirements, and relevant standards.

* Provide on-floor support to Manufacturing teams for equipment and process troubleshooting, ensuring issues are promptly identified and documented in the appropriate quality management system.

* Lead or support root cause analyses for process and equipment issues and ensure appropriate corrective and preventive actions are defined, implemented, and followed through.

* Ensure that changes, maintenance activities, and other interventions do not adversely impact the qualified or validated state of equipment and processes.

* Provide oversight for maintenance activities on process equipment and ensure all changes are documented accurately through the change management system.

* Use data-driven analysis of process and equipment performance to understand capacity, efficiency, and variability, and identify opportunities for optimization.

* Recommend and implement process and equipment improvements to enhance system performance, reliability, and throughput.

* Ensure process operations comply with all health, safety, and environmental policies and procedures, and support a strong safety culture.

* Participate in HAZOP and process safety reviews, identifying and mitigating hazards associated with manufacturing processes and equipment.

* Demonstrate strict adherence to local, state, and federal requirements, cGMP standards, and internal policies and procedures, consistently modeling a "Safety First and Quality Always" mindset.

* Attend, complete, and maintain required training to stay current with industry standards, regulatory expectations, and internal procedures.

Essential Skills

* Minimum of 2 years of experience in process engineering, preferably within the pharmaceutical or animal health industry.

* Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering field.

* Strong analytical and problem-solving skills with the ability to apply data-driven approaches to process and equipment performance.

* Proficiency in fill finish processes and related manufacturing operations.

* In-depth understanding of process engineering principles and their application in a regulated manufacturing environment.

* Proven experience working within cGMP (current Good Manufacturing Practices) and FDA-compliant operations.

* Solid knowledge of regulatory requirements and industry best practices for pharmaceutical and animal health manufacturing.

* Excellent communication abilities, with the capacity to collaborate effectively with production, maintenance, quality, and safety teams.

Additional

Skills & Qualifications

* Experience in process troubleshooting and root cause analysis within a manufacturing setting.

* Familiarity with quality management systems and change management processes.

* Experience participating in HAZOP and process safety reviews.

* Demonstrated commitment to health, safety, and environmental compliance.

* Ability to work effectively in a small, collaborative team environment and manage multiple priorities.

* Comfort working both on the manufacturing floor and in an office setting.

Work Environment

The role is based in a combined…