Production Process Owner: Manufacturing Ops & Compliance

CSL; Kankakee, Northern (IL, KY); Ibrido; USD 101.000 - 120.000; Tempo pieno

Descrizione del lavoro

CSL Behring in the United States (Kankakee area) is seeking a Production Owner who acts as the process SME to ensure critical quality attributes, CPPs, and regulatory commitments are understood, controlled, documented, and executed reliably.

The role partners with Manufacturing, Quality and Engineering to maintain robust control strategies, monitor performance via data, and drive continuous improvement, training, and inspection readiness while upholding CSL values.

Competenze

• Bachelor’s degree in Science or Engineering or equivalent experience.
• 3+ years in pharmaceutical or biotech manufacturing.
• Experience with regulatory inspections and compliance.
• Audit and investigation skills; report writing skills.
• Strong verbal, technical writing and interpersonal skills; Lean six sigma a plus.

Mansioni

• Serve as the process SME for assigned manufacturing processes.
• Demonstrate deep understanding of CQAs, CPPs, and regulatory filings.
• Understand what aspects of process outputs are critical to internal customers.
• Monitor process performance using data and summarize performance into dashboards.
• Own and maintain SOPs and batch records for process operations.
• Collaborate with Manufacturing, Quality, and Facilities & Engineering to maintain control strategies.
• Support continuous improvement, safety, and regulatory readiness.

Conoscenze

Process ownership

Data analysis

Regulatory inspections

Quality documentation

Cross-functional collaboration

Formazione

Bachelor's degree in Science or Engineering

Descrizione del lavoro

CSL Behring in the United States (Kankakee area) is seeking a Production Owner who acts as the process SME to ensure critical quality attributes, CPPs, and regulatory commitments are understood, controlled, documented, and executed reliably.

The role partners with Manufacturing, Quality and Engineering to maintain robust control strategies, monitor performance via data, and drive continuous improvement, training, and inspection readiness while upholding CSL values.