Manager, Manufacturing Engineering

Agilent Technologies • Frederick, CO

111d • $124,160 - $194,000

About The Position

The Manufacturing Engineer Manager position provides direction for a wide variety of technical duties to support manufacturing operations. This role involves overseeing and supporting the transfer and scale-up of new processes from Process Development into Manufacturing, attending and participating in project team meetings to develop and execute project plans. The position requires interfacing with Process Development, Project Management, and Manufacturing to ensure small-scale development activities will scale to manufacturing equipment and systems. Responsibilities include reviewing and approving technology transfer documents, writing or reviewing new process documentation, coordinating the revision of standard operating procedures (SOPs), supervising MFG Engineers, and assisting manufacturing with problem solving and troubleshooting process or process equipment. The role also involves leading investigations of major process deviations and providing technical assistance to Quality Assurance (QA).

Requirements

• Bachelor's degree in chemistry, biology, engineering or related life science field; or an equivalent combination of education and related experience.
• 5+ years of experience in manufacturing engineering or process engineering, preferably in a regulated industry (e.g., pharmaceuticals, biotech, medical devices).
• 1+ years of leadership or supervisory experience managing engineering teams or cross-functional projects.
• Prior experience in a GMP manufacturing facility preferred.

Responsibilities

• Oversees and supports the transfer and scale-up of new processes from Process Development into Manufacturing.
• Attends and participates in project team meetings to develop and execute project plans.
• Interfaces with Process Development, Project Management, and Manufacturing to ensure small-scale development activities will scale to manufacturing equipment and systems.
• Responsible for the review and approval of technology transfer documents from Process Development.
• Responsible for writing or reviewing new process documentation (master batch records or data capture forms) and automated equipment methods.
• Coordinate the revision of standard operating procedures (SOPs) as required to support the transfer.
• Supervises activities and projects of the MFG Engineers.
• Provides technical guidance on project execution and implementation.
• Directs MFG Engineers during the scale-up of existing processes in Manufacturing.
• Oversees, supports, and is responsible for writing and/or reviewing scale-up batch documentation, change controls, and automated equipment methods.
• Coordinate the creation and/or revision of SOPs as required to support the scale-up.
• Responsible for the generation and/or review of batch summaries for all batches produced in the manufacturing facilities.
• Oversees, supports, and is responsible for communicating future development requirements or opportunities to the project team.
• Assist manufacturing with problem solving and troubleshooting process or process equipment.
• Actively lead or participate in the investigation of major process deviations.

Benefits

• Eligibility for bonus, stock and benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees