The Process Owner will collaborate with Manufacturing, Quality, and Facilities & Engineering to ensure it continues to meet internal customer, business, and patient needs. The primary aim of the role is to lead key process transformation, design and improvement efforts. The Process Owner will lead a mix of strategic and tactical assignments of various complexities each with an opportunity to achieve measurable results. The incumbent will exhibit knowledge and provide coaching/training to colleagues while leading process and quality initiatives, as necessary. This position is with Fractionation.

Responsibilities:

• Demonstrated ability to understand what is critical about the process.
• Monitors process performance with data by including both input/process parameters and output measures. Monitor data compiled by process operators and summarize into a dashboard.
• Ensures the process is documented, and that the documentation is used and updated routinely.
• Closely collaborates with internal and global functions (Manufacturing, Quality, and Facilities & Engineering) to ensure a control plan is in place.
• Ensures that any improvements identified through projects are incorporated and maintained in the process.
• Act as Process SME during internal and/or external Regulatory inspections.
• Provides necessary training and resources for the process operators to do their jobs well and keep getting better. Resources may include appropriate training, materials, information, and equipment.

• 4+ years of relevant experience and a BS
• 2+ years of relevant experience and a MS. •
• Prior experience in pharmaceutical industry is preferred.
• Proficient knowledge of Good Manufacturing Practices (GMPs)
• Audit and Investigation Skills, Report Writing Skills.
• Strong verbal, technical writing and interpersonal skills are required.
• Proficiency in Microsoft Office applications.
• Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.