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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.

OBJECTIVES/PURPOSE

The Calibration and Maintenance Lab (CML) is responsible for ensuring BioLife equipment is suitable for its intended use, properly maintained in a good state of repair, and continues to operate in a validated state.

CML is 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 is primarily responsible for the qualification, validation, and new technology aspects, but supports all CML responsibilities as necessary. 

The Equipment Validation Associate owns, executes, and continuously improves the above-mentioned CML processes.  They are expected to provide coaching and guidance to key stakeholders including BioLife Centers, Engineering teams, and Quality Operations.  

ACCOUNTABILITIES

• Qualifying and Validating BioLife Equipment (including Freezers)
• Training, qualifying, and overseeing field validators
• Maintaining and coordinating the validation schedule and supplies
• Supporting new technologies and equipment being pursued by BioLife
• Supporting growth and improvement initiatives and project teams
• Maintaining Qualification and Validation processes in compliance with applicable regulations and industry standards
• Owning, executing, approving, maintaining, improving, consulting, and coaching on responsible CML processes and associated records generated by them
• Providing necessary BioLife Operational support to ensure no equipment related disruptions impact Source plasma collections

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise  

• Experience in a regulated industry

Leadership

• Self-motivated
• Strong communication skills (written and oral)
• Team oriented
• Ability to manage, prioritize and deliver on core responsibilities in a fast paced and dynamic environment

Decision-making and Autonomy

• Comfortable making decisions within the sphere of control
• Comfortable asking questions and seeking feedback on situations
• Ability to identify and propose solutions to problems as they arise
• Ability to understand the risks and benefits surrounding decisions

Interaction

• Customer focus – willingness to help, respectful, prompt, and accountable
• Partner with Quality Departments, Engineering, and Center Operations

Innovation

• Open to new ideas
• Embrace change
• Confidence in challenging the status quo

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 potential upstream/downstream impact of decisions

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

Essential

• Highschool diploma or GED
• Experience with Microsoft Word, Excel and SharePoint

Desired

• At least 3 years of experience in a regulated industry
• Bachelor's degree in Science or Engineering
• Experience with Equipment maintenance and lifecycle
• Experience with Validation
• Understanding of plasma collection business and associated regulations

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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