Biologics Process Engineer – GMP Manufacturing (Onsite)

Catalent; Madison (WI); Sur place; USD 80 000 - 120 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision benefits

Tuition reimbursement

Career growth opportunities

Résumé du poste

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. We seek a Process Engineer - Engineering to join our team and contribute to process optimization and troubleshooting in a dynamic, innovation‑driven environment.

The role operates 100% onsite in Madison, WI with standard daytime shifts (Mon–Fri) and cross‑functional collaboration across divisions to advance

Qualifications

• Bachelor's degree in a scientific/engineering field with 3+ years in facilities operation or automation in a cGMP environment (biopharmaceutical preferred).
• Master's degree with 1+ year in facilities operation or automation in a cGMP environment (biopharmaceutical preferred).
• Requires sitting, standing, walking, reading, computer use, and occasional lifting up to 50 pounds.

Responsabilités

• Evaluate existing processes and identify improvements to enhance efficiency, cost savings, time savings, consistency, and competitiveness.
• Lead technical support for risk assessments, gap analysis, deviations, change controls, and corrective actions, including root-cause analysis.
• Support drafting and development of User Required Specifications and participate in QA testing and validation activities.
• Lead site strategy projects with cross‑department resources and Site Leadership Team visibility through implementation.
• Oversee technical support of Manufacturing, including change management, troubleshooting, and project oversight.
• Support lifecycle management of consumables and raw materials for single‑use GMP manufacturing.
• Track, trend, and analyze data for compliance, product quality, continuous improvement, and investigations.
• Perform other duties as assigned.

Connaissances

Cross-department leadership

Data analysis

Process improvement

Root-cause analysis

Technical reporting

SOP writing

Formation

Bachelor's degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related field

Master's degree in Industrial, Electrical, Mechanical, Chemical, Computer Science, Civil Engineering, or related field

Description du poste

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. We seek a Process Engineer - Engineering to join our team and contribute to process optimization and troubleshooting in a dynamic, innovation‑driven environment.

The role operates 100% onsite in Madison, WI with standard daytime shifts (Mon–Fri) and cross‑functional collaboration across divisions to advance