What are the responsibilities and job description for the Process Engineer position at Azzur Group?
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.
- 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.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
