Qualifications

• Bachelor of Science in Chemical Engineering or similar field.
• 5-7 years of experience in cGMP manufacturing or process engineering.
• Understanding of GMP regulations and FDA guidelines.
• Experience with bioprocessing equipment in a GMP environment preferred.
• Strong communication skills and ability to work cross-functionally.
• Familiarity with quality management systems, CAPA, and change control procedures.
• Experience in Lean Manufacturing and Six Sigma methodologies.

Responsibilities

• Collaborate to enhance health, safety, and environmental processes.
• Analyze current manufacturing processes and implement improvements.
• Troubleshoot production activities on the shop floor and enforce safety protocols.
• Integrate new products with manufacturing teams and optimize launch processes.
• Lead investigations into manufacturing deviations and establish corrective actions.
• Utilize knowledge to improve equipment functionality and efficiency.
• Support implementation of production equipment including design and qualification activities.
• Propose and revise Standard Operating Procedures for clarity and consistency in production.
• Maintain accuracy of Bill of Materials and Electronic Batch Records for products.
• Assess technical impacts during management of change processes.

Benefits

• Medical, Dental, Vision insurance.
• Life insurance coverage.
• 401k retirement plan.
• Paid Time Off for employees.