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Validation Manager

Validation Manager

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Validation professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Validation at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.

Department Description:

The Validation Department provides documented evidence that Operational equipment, systems, and processes involved in commercial product manufacturing, perform in a qualified and reproducible manner, and comply with regulatory compliance requirements and current industry/Vericel policy and guidance. The deliverables of the Validation Department include approved Validation protocols and Final Reports. The department also functions as the liaison with Metrology/Calibration Vendors and performs all equipment ownership and quality review responsibilities associated with site calibration activities.

Position Summary:

Manage a validation group responsible for the management, development and execution of Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, requalification and Process Validation activities. Oversees department schedules, ensuring compliance with appropriate regulatory agency requirements, internal company policies and current industry practices. 

ESSENTIAL FUNCTIONS

Core Responsibilities:

All duties of a Validation Supervisor, as well as the following:

  • Manage validation department personnel including performance evaluation, career development, mentoring and coaching.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Leaderships Qualifications:

Leadership qualifications include, among other requirements:

  • Understanding, observing, and adhering to the goals and policies outlined in Vericel’s Code of Business Conduct and Ethics
  • Being honest and treating people with respect and courtesy.
  • Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
  • Serving as role models for our fellow employees and business partners by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Engineering/science bachelor’s degree with a minimum of 6-8 years of validation experience, or master’s degree with a minimum of 2-4 years’ experience.
  • Experience in process, equipment, utility, and/or software validation in a GMP regulated environment.

Preferred Qualifications:

  • Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
  • Working knowledge of GMPs.
  • Excellent technical writing and verbal communication skills.
  • Basic math and statistical skills.
  • Must be people oriented and a team player.
  • Experience with Microsoft Office including Excel, PowerPoint, Word, Project and Visio.
  • Familiarity with temperature chambers, sterilization, cleaning, software and depyrogenation qualifications.
  • Prior experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution.
  • Experience with writing validation protocols, project plans and final reports and managing validation projects.
  • Ability to read/interpret engineering drawings and design documents.
  • Knowledge of risk management tools and techniques.
  • Prior experience supervising personnel.

WORKING CONDITIONS AND PHYSICAL DEMANDS

  • May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

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4:00 PM on
May 19, 2022
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