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Job Description

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.

OBJECTIVES/PURPOSE

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.  This role is specifically accountable for the qualification and validation components.  

ACCOUNTABILITIES

• 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  

• Experience in a regulated industry
• Equipment lifecycle experience
• Validation experience

Leadership

• Self-motivated
• Strong communication skills (written and oral)
• Team oriented
• 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

Interaction

• Available and present for team member support
• Customer focus – 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

Innovation

• Creative thinker
• Open to new ideas
• Embraces change

Complexity

• 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: 

Essential

• Minimum of 8 years' experience in a regulated industry
• Highschool diploma or GED
• Minimum of 5 years' experience in equipment management

Desired

• Bachelor's degree in Science or Engineering
• Understanding of plasma collection business and associated regulations

ADDITIONAL INFORMATION

• Domestic travel up to 25%

EEO Statement

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.

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