Process Owner
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.
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.
Qualifications:
Bachelor's Degree in Mechanical, Chemical or Manufacturing Engineering or equivalent degree may be considered dependent upon experience.
- 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.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
