Quality / Maintenance Manager, Equipment and Validation (t960)

Quality Manager, Equipment and Validation

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.

The 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 accountable for the repair, preventive maintenance, and calibration of Plasma Center equipment, but supports all CML responsibilities, as required.
* The Equipment Management Associate owns, executes, and continuously improves the
abovementioned CML processes.

* They will additionally provide coaching and guidance to key
stakeholders including BioLife Centers, Engineering teams, and Quality Operations.

ACCOUNTABILITIES
· Repair of small equipment (e.g. tube sealers and centrifuges)
· Receiving and preparing equipment for:

o Repair
o Maintenance
o Calibration
o Decommissioning
o Project and New Center Support

· Data entry into the asset management system (e.g. CMS)
· Supporting growth, improvement initiatives, and team projects
· Providing necessary support to ensure no equipment related disruptions impact BioLife center
and/or Manufacturing Operations.

DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
· Experience in a regulated industry
· Equipment Repair/Mainteannce
· Basic computer skills including familiarity with Mircrosoft software (i.e. Outlook and Excel)

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, Facilities, 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
· Must be able to lift up to 30 lbs
**Desired
· Bachelor’s degree in Science or Engineering
· At least 3 years of experience in a regulated industry
· Experience with Equipment maintenance and lifecycle
· Understanding of plasma collection business and associated regulations.