Senior Biologics MS&T Process Engineer

Catalent Pharma Solutions; Madison (WI); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Career growth

Inclusive culture

Benefits from day one

Tuition reimbursement

Job summary

Catalent’s Madison, WI site is a state-of-the-art biologics development and manufacturing facility supporting customers from research through early-and mid-stage clinical production. The Principal Process Engineer - Manufacturing Sciences & Technology provides on-call and on-the-floor technical support to manufacturing.

The role involves drafting and reviewing documentation, compiling process data, and guiding investigations and change controls.

Qualifications

• Experience in documenting and revising technical documents and batch production records.
• Experience using statistical techniques for data analysis and reporting.
• Direct personnel management including mentoring and training staff cross-functionally.
• Experience investigating deviations, implementing CAPAs and closing investigations.

Responsibilities

• Develop technical work plans and schedules for projects.
• Author and approve protocols, tech transfer reports, and batch records.
• Collaborate with cross-functional teams to transfer processes and maintain GMP standards.
• Provide technical oversight for risk assessments, deviations, and CAPAs.
• Lead client meetings and support multiple customers across sites.

Skills

Process engineering leadership

Documentation

Statistical data analysis

Team mentoring

Technology transfer

GMP knowledge

Education

Bachelor's degree in STEM

Master's degree in STEM

Doctorate in STEM

Tools

Single-use systems

Process equipment troubleshooting

Tech transfer

Job description

Catalent’s Madison, WI site is a state-of-the-art biologics development and manufacturing facility supporting customers from research through early-and mid-stage clinical production. The Principal Process Engineer - Manufacturing Sciences & Technology provides on-call and on-the-floor technical support to manufacturing.

The role involves drafting and reviewing documentation, compiling process data, and guiding investigations and change controls.