About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
The Calibration and Maintenance Lab (CML) is responsible for ensuring BioLife equipment is suitable for intended use, properly maintained in a good state of repair, and continues to operate in a validated state.
They are responsible for the equipment lifecycle including testing and assessing new technologies, configuring, qualifying, and validating new equipment, evaluating the impact of changes, managing repairs, managing maintenance and calibration, and decommissioning of faulty and expired equipment.
This position oversees a team responsible for owning, executing, and continuously improving the above-mentioned processes.Â This role is specifically accountable for the qualification and validation components.Â Â
Managing, developing, training, and coaching the CML Validation team
Leading and supporting growth and continuous improvement initiatives
Providing necessary BioLife Operational support to ensure no equipment related disruptions that impact Source plasma collections
Qualifying and Validating BioLife Equipment (including Freezers)
Maintaining Qualification and Validation processes in compliance with applicable regulations and industry standards
Training, qualifying, and overseeing field validators
Maintaining and coordinating the validation schedule and supplies inventory
Continuous improvement of responsible processes
Subject matter expert for responsible processes
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise Â
Experience in a regulated industry
Equipment lifecycle experience
Strong communication skills (written and oral)
Ability to manage, prioritize and deliver on core responsibilities
Drives team accountability
Ensures team have appropriate resources and support to conduct their tasks
Decision-making and Autonomy
Comfortable making decisions with limited information
Ability to identify and resolve problems as they arise
Ability to understand the risks and benefits surrounding decisions
Not afriad to challenge the status quo
Available and present for team member support
Customer focus â willingness to help, respectful, prompt and accountable
Partners with Corporate business process owners, PDT/BioLife operational departments, PDT/BioLife Quality departments, and BioLife Center Operations
Open to new ideas
Ability to thrive in a dynamic setting
Ability to break down complex situations into executable pieces
Ability to see the big picture and the upstream/downstream impact of decisions
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Â
Minimum of 8 years' experience in a regulated industry
Highschool diploma or GED
Minimum of 5 years' experience in equipment management
Bachelor's degree in Science or Engineering
Understanding of plasma collection business and associated regulations
Domestic travel up to 25%
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.