Supervisor, Validation Engineering

Supervisor, Validation Engineering

Department Description:

The Validation department performs equipment, utility, cleaning, sterilization, software, and process validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for cell therapy products. The department also functions as the liaison with the metrology coordinator and performs all equipment ownership and quality assurance review responsibilities associated with site calibration activities.

Position Summary:

Responsible for supervising validation personnel and activities in a GMP-regulated biotechnology manufacturing facility.

Core Responsibilities:

All duties of a Validation Engineer II, as well as the following:

  • Manage validation department personnel including performance evaluation, career development, mentoring and coaching.
  • Coordinate validation events with third party vendors.
  • Coordinate and assist on-site contractors with validation activities.
  • Comply with the regulatory compliance environment within Vericel.
  • Create and maintain department standard operating procedures.
  • Assist in internal and external audits.
  • Complete department TrackWise records relative to deviations, CAPAs and change controls.
  • Respond to various internal and external inquiries for information.
  • Adhere to all relevant internal and external policies and guidelines related to the team’s activities and deliverables.
  • Communicate effectively with management, team members and personnel in other departments.
  • Interact with internal project teams and cross functional groups (such as QA, QC, Materials Management, Facilities & Engineering, Manufacturing Operations, Support, Training, and Customer Care) on requests and scheduling.
  • Assist with department daily activities as directed by management.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • 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.
  • Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of our products and services. This includes:

  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
  • 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.
  • Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

  • Bachelor's Degree or equivalent and 6+ years of validation experience, or
  • Master’s Degree or equivalent and 4+ years of validation experience.
  • 3-4 years of experience with process, equipment, utility and/or software validation in a GMP-regulated environment.
  • 1+ year supervising experience.

Preferred Qualifications:

  • Experience 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 applications including Excel, PowerPoint, Word, Project and Visio.
  • Familiarity with temperature chamber, sterilization, cleaning, software and depyrogenation qualifications.
  • Experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution.
  • Experience writing / reviewing validation protocols, project plans and final reports and managing validation projects.
  • Ability to read/ interpret engineering drawings and design documents.
  • Experience with risk management tools and techniques.
  • Experience with TrackWise quality management software.
  • Experience working within cross-functional teams.

Working Conditions and Physical Demands

  • May require working in a cleanroom manufacturing environment including gowning.
  • Personal protective equipment must be worn due to safety requirements.
  • Able to lift, push or pull up to 40 pounds.
  • Must be willing to work outside of standard working hours as required to meet department demands.


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 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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June 14, 2019
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