Process Engineer

We are seeking a highly motivated Process Engineer to join our team in supporting manufacturing operations and process improvement initiatives in a cGMP-regulated pharmaceutical environment. The successful candidate will optimize existing processes, develop new methods, and ensure compliance with regulatory standards to enhance production efficiency and product quality.

Responsibilities:

• Develop and optimize manufacturing processes for pharmaceutical products, ensuring efficiency, scalability, and compliance.
• Analyze process data to identify areas of improvement and implement solutions to increase throughput, reduce cycle time, and minimize waste.
• Collaborate with cross-functional teams to design, procure, and qualify new equipment or modify existing systems.
• Support commissioning, qualification, and validation (CQV) activities for process equipment, including writing protocols and executing test plans.
• Prepare and maintain detailed technical documentation, including SOPs, batch records, and process flow diagrams, in compliance with cGMP and regulatory requirements.
• Participate in internal and external audits, providing technical expertise as needed.
• Investigate deviations and process failures using root cause analysis tools to implement corrective and preventive actions (CAPA).
• Support resolution of technical challenges encountered in manufacturing and laboratory environments.
• Lead continuous improvement projects to enhance safety, efficiency, and quality in production processes.
• Stay updated on industry best practices, technological advancements, and regulatory changes to incorporate into operations.

Requirements

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related field.
• 38 years of experience in process engineering within the pharmaceutical, biotechnology, or life sciences industry.
• Familiarity with cGMP regulations, FDA guidelines, and industry standards.
• Proficient in process mapping, statistical analysis, and equipment troubleshooting.
• Experience with single-use systems, bioreactors, filtration, or other pharmaceutical manufacturing technologies.
• Working knowledge of process validation and risk assessment methodologies.
• Strong problem-solving, communication, and project management skills.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Qualification

Bachelor's Degree