Job Description

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Job Summary

nnZimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

This position is responsible for supporting the validation of various systems across the manufacturing areas of the in-vitro diagnostic division. Goal is to assure the validation programs are compliant with corporate and global standards. Strong communication, leadership and organizational skills are essential as well as a full understanding of the manufacturing process.

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Principal Duties and Responsibilities

nn Carry out all aspects of a validation including: Authoring/reviewing/executing Validation Master Plan (VMP), Validation Plan (VP), User Requirements Specifications (URS), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ),and Performance Qualification (PQ) protocols/report, risk assessments, and periodic reviews in accordance with corporate and departmental procedures
Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to ensure correct interpretation of the information
Participate on cross-functional teams to address specific problems, facilitate discussion, research and assist with deviations investigation, change controls write-up
Provide technical input with respect to Standard Operating Procedures development; review or revise SOPs as required to assure that all needs are addressed, and compliance and industry standards are incorporated
Develop the site requalification plan and strategy, execution, and implementation; must be able to evaluate current processes and procedures and lead a validation team
Maintain validation requirements, practices, and procedures and coach other members of the team participating in validation activities
Ensure that projects are implemented in accordance to the agreed upon scope and time lines.

This is not an exhaustive list of duties or functions and may not necessarily comprise all the essential functions for purposes of the ADA.

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Expected Areas of Competence

nn Ability to define requirements, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions.
Competent (with a proven track record) in the writing and executing successful validation plans.
Knowledge of post-implementation continuous improvement efforts and methodology.
Establishes manufacturing methods which meets performance and quality requirements.
Strong project management skills with the ability to coach, develop, and manage others.
Proficiency with using Microsoft Office Suite
Ability to work with mathematical concepts such as probability and statistical inference
Ability to influence clients, suppliers and peers into adopting best practices in the engineering field

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Education/Experience Requirements

nn Minimum B.S. in a relevant engineering field
Minimum of 6 years of progressive experience in manufacturing engineering, operations or related field writing and executing validation documents.
Prior experience interfacing with regulatory agencies, as well as exposure to the regulatory submission process
In-vitro diagnostic experience preferred.

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Travel Requirements

nnUp to 5%

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Additional Information

nnEOE/M/W/Vet/Disability

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

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