Process Engineer II/III

The Process Engineer II / III will provide engineering support and leadership for Drug Substance Manufacturing operations, including cell culture, purification, and/or preparation operations for process buffers and small equipment. This role will be a technical leader who is responsible for process equipment troubleshooting as well as the design, procurement, installation, and start-up of process equipment systems for an entire operational area.

Responsibilities:

• Provides technical management and expertise for the design, procurement, fabrication, and/or commissioning phases associated with custom equipment and/or automation of manufacturing systems.
• Leads cross-functional teams for technical continuous improvement projects.
• Plans the execution of start-up and commissioning activities for assigned systems for an operational area.
• Troubleshoots complex equipment- or automation-related issues and develops sound engineering solutions to address identified problems.
• Supports the development of engineering standards and best practices.
• Seeks out and implements performance and reliability improvements for assigned systems.
• Owns or supports complex small projects and/or capital projects, including change management strategies.
• Leads complex deviation investigations related to process equipment to identify root cause and implement appropriate corrective and preventive actions (CAPAs) to prevent reoccurrence. Demonstrates mastery of root cause analysis methodologies.
• Trains other engineers and technical staff (Engineer III).

Qualifications:

• Bachelor’s degree in Engineering or related technical field.

• Bachelor’s degree with 3+ years (Engineer II) or 7+ years (Engineer III) of related industry
experience, or Master’s degree with 1+ years (Engineer II) or 4+ years (Engineer III) of
experience.
• Direct experience in pharmaceutical/biotech operations or other regulated environments (e.g.,
cGMP, OSHA, EPA).
• Design experience with pharmaceutical or biotech process or automation systems.
• Experience with medium or large projects to implement new or modified process equipment.
• Experience with cell culture/fermentation or protein purification processes is preferred.

Occupational Standards:

Bending/Reaching • For equipment operation or material movement tasks
Computer Use • May be for greater than 4 hours per day
Noise • Environment may exceed 80 decibels
Walking/Standing • Up to 8 hours throughout the workday
Lifting • Up to 40 lb