Senior Process Engineer – Pharma Manufacturing & Automation

CSL; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

CSL Seqirus is seeking an engineering leader to provide technical management for Drug Substance Manufacturing operations, including cell culture, purification, and preparation of process buffers and small equipment.

You will lead design, procurement, installation, and start-up of process equipment systems for an entire operational area, and onsite execution five days a week, with responsibility for debugging, CAPAs, and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or related field with 7+ years of experience (or Master’s with 4+ years).
• Experience in pharmaceutical/biotech operations or other regulated environments (cGMP, OSHA, EPA).
• Design experience with pharma/biotech process or automation systems.
• Experience with medium/large projects to implement new or modified process equipment.
• Experience with cell culture/fermentation or protein purification preferred.

Responsibilities

• Provides technical management and expertise for design, procurement, fabrication, and commissioning phases for custom equipment or automation of manufacturing systems.
• Leads cross-functional teams for technical continuous improvement projects.
• Plans start-up and commissioning activities for assigned systems.
• Troubleshoots complex equipment- or automation-related issues and develops engineering solutions.
• Supports development of engineering standards and best practices.
• Seeks performance and reliability improvements for assigned systems.
• Owns or supports complex small projects and/or capital projects, including change management strategies.
• Leads deviation investigations to identify root cause and implement CAPAs to prevent recurrence.
• Trains other engineers and technical staff.

Skills

Technical leadership

Troubleshooting

CAPA/root cause analysis

Cross-functional leadership

Equipment design

Project management

Training others

Education

Bachelor’s degree in Engineering or related field

Master’s degree in Engineering or related field

Tools

Pharma/biotech process design tools

Automation systems design

Job description

CSL Seqirus is seeking an engineering leader to provide technical management for Drug Substance Manufacturing operations, including cell culture, purification, and preparation of process buffers and small equipment.

You will lead design, procurement, installation, and start-up of process equipment systems for an entire operational area, and onsite execution five days a week, with responsibility for debugging, CAPAs, and continuous improvement.