Validation Specialist
The Validation Specialist at Legend Biotech US plays a pivotal role in ensuring the compliance and efficiency of manufacturing processes within the company's cell therapy production facility. This position is integral to maintaining the integrity of aseptic processes and equipment qualifications, directly impacting the quality of life-saving therapeutics developed by the company.
In this role, the Validation Specialist is responsible for executing site validation activities in accordance with current regulatory and site requirements. Key duties include overseeing aseptic process validation, managing equipment process qualifications, and supporting the investigation of validation challenges. The specialist also plays a crucial role in establishing key performance indicators (KPIs) and executing routine process performance qualification (PPQ) and operational performance qualification (OPQ) reporting. Additionally, the role involves providing technical assessments and approvals for engineering and process changes to meet regulatory standards.
Candidates for this position should possess a Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field. A minimum of two years of experience in validation or manufacturing/process engineering within the pharmaceutical or biopharmaceutical industry is required. Specialized skills in process validation, equipment qualification, aseptic processing, and writing or supporting Quality Risk Assessments are essential.
The compensation for this role includes a base salary of $120,000 per year. Additional benefits encompass medical, dental, and vision insurance, a 401(k) retirement plan with company matching, and eight weeks of paid parental leave after just three months of employment. The company also offers a comprehensive paid time off policy, including vacation, personal, sick, and floating holidays, along with eleven company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs are also available.
Legend Biotech US fosters a collaborative and innovative work environment, emphasizing the development of cutting-edge cell therapies. Employees are encouraged to contribute to the discovery of safe and efficacious therapeutics for patients worldwide. The company offers opportunities for professional growth and advancement within the biotechnology sector, making it an attractive workplace for individuals passionate about making a meaningful impact in the field of cell therapy.