The employee will work as part of cross-functional team providing quality oversight, review, execution, and approval for validation deliverables to ensure the process and products meet appropriate regulatory agency validation requirements, internal company standards, and cGMP. This position will typically focus on disciplines related to requalification of equipment, process, control systems, and computer system validations.
Primary Responsibilities:
- Leads preparation, execution, data collection, and authoring validation reports under direct supervision
- Prepares validation protocols, reports, test equipment, and evaluates validation test results for data integrity and accuracy
- Authors and prepares summary reports to determine pass/fail results
- Develops programs and maintain standard operating procedures (SOP)
- Support document management via Learning Management System (LMS), GxP Training, and GDRS
- Demonstrates effective communication regarding assigned study activities and project deliverables
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Minimum Qualifications:
- Bachelor of Science in Engineering, Biotechnology, or Science discipline (e.g. Chemistry, Biology, Microbiology, etc.)
- Minimum 3 years' experience in the Pharmaceutical/Biotech Industry
- Minimum 1-year experience in a validation role in pharmaceutical manufacturing
The expected base salary range for this position at hiring is $70,000 - $100,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Our Benefits
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.
About CSL Behring
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.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!