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 therapies products. The department also functions as the liaison with the Metrology department and performs all equipment ownership and quality assurance review responsibilities associated with site calibration activities.
Responsible for performing validation in a GMP biotech manufacturing facility.
This position requires both individual responsibilities and supervision of validation engineers, including:
- Manage validation department personnel including performance evaluation, career development, mentoring and coaching
- Lead Validation group meetings and collecting and monitoring validation group performance metrics
- Lead complex validation projects, and the validation aspects of multi-departmental projects
- Ensure timely execution and closure of scheduled requalifications
- Ensure timely completion of project activities, including development of system lifecycle documentation, risk assessments, qualifications, and reports.
- Identify and implement improvements to validation systems
- Supervise the calibration system and Calibration Coordinator to ensure that scheduled and ad hoc calibrations are performed as required
- Serve as subject matter expert (SME) for facilities, utilities, and equipment commissioning and qualification (C&Q)
- Train Validation Engineers on validation concepts and techniques
- Support investigations into failures of qualified systems, leading as appropriate
- Develop and revise Validation SOPs to maintain the system in a state of compliance and efficient operation
- Write, review, and approve validation documentation, including protocols and reports
- Stay current with industry guidance documents and trends impacting Validation
- Establish and support a culture of compliance, professionalism, and high performance within the Validation group
QUALIFICATIONS, EDUCATION AND EXPERIENCE
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 all 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.
- 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.
- 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 chamber, 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.
- Able to lift up to 40 lbs.
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.