Process Engineer

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

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.
• 3–8 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

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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