Production Engineer

About the role

The Production Engineer bridges the gap between engineering and manufacturing. They actively participate in optimizing assigned processes, troubleshoot issues on the production floor, and manage engineering projects impacting production of liquid & powder media, diagnostic kits, and biological products manufactured by our company.

Responsibilities

• Collaborate with team members to improve processes related to health, safety and environment.
• Analyze and identify areas for improvement in current manufacturing processes.
• Implement solutions to enhance efficiency, quality, and yield.
• Actively participate in and troubleshoot production activities on the shop floor.
• Ensure adherence to established procedures and safety protocols.
• Collaborate with manufacturing teams to integrate new products seamlessly.
• Identify and optimize processes for successful production launches.
• Lead investigations into deviations and non-conformances.
• Develop and implement corrective and preventative actions to minimize future occurrences.
• Utilize process and utility system knowledge to improve equipment functionality and overall manufacturing efficiency.
• Support the implementation of new production equipment, including design, procurement, cGMP documentation, commissioning, and qualification activities.
• Propose, write, review, and revise departmental Standard Operating Procedures (SOPs) to ensure clarity, consistency, and quality in production practices.
• Work cross functionally to maintain and improve the accuracy of Bill of Materials (BOM) and Electronic Batch Records (EBRs) for existing products.
• Provide technical feedback and ensure completeness during the setup of new parts and processes.
• Provide technical assessment and ensure any impact to manufacturing is captured during management of change process.

Qualifications

• Bachelor of Science in Chemical Engineering, or similar Scientific/Engineering background.
• 5-7 years of experience in manufacturing engineering, process engineering, project engineering, or similar role in a cGMP environment.
• Understanding of Good Manufacturing Practice (GMP) regulations and guidelines set forth by regulatory agencies, such as the FDA, for the manufacturing of life science products.
• Prior experience working in a GMP manufacturing environment with a variety of bioprocessing equipment is highly preferred.
• Excellent communication and customer-oriented skills with ability to work in a matrix / cross-functional organization.
• Knowledge and experience working within a quality management system, including investigation resolution, Corrective and Preventative Action (CAPA) implementation, and change control procedures.
• Familiarity with and ability to apply concepts of Lean Manufacturing for waste reduction and process optimization, and Six Sigma for quality improvement methodologies.
• Prior experience working in the life sciences industry is a plus.
• Ability to speak, read, and write in English.
• Good oral and written communication skills.

Pay

For California, the base salary range for this position is $91,105.30 - $118,752.45. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

Benefits

• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off