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 projects and managing a team of validation specialists in a GMP biotech manufacturing facility.
- Support completion of validation activities in the media preparation, cell culture, utilities and QC areas of a cGMP biotech manufacturing facility.
- Perform hands on execution of Installation, Operational and Performance Qualifications for equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols.
- Analyze validation results and compile data into reports for initial qualifications and requalifications.
- Coordinate testing schedule with impacted area managers and quality control based on project needs.
- Provide input to technical composition of standard operation procedures.
- Develop and publish new validation project plans and protocols, execute protocols and write final reports with little to no supervision.
- Create department standard operating procedures.
- Investigate and troubleshoot validation problems.
- Participate in equipment failure investigations, corrective/preventive actions and equipment release. Provide final approval for equipment release.
- Contribute to the successful completion of project milestones and crucial technical tasks.
- Participate in corporate standard implementation.
- Manage validation department personnel including performance evaluation, career development, mentoring and coaching.
- Provide technical assistance to less experienced technicians/specialists.
- Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
- Review and approve validation and calibration documentation.
- Represents the validation department and acts as a technical contact on projects.
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 5-8 years of experience.
- Master’s Degree or equivalent and 3-6 years of experience.
- 3-4 years of experienced 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.
- Knowledge of international regulatory requirements.
- Prior experience supervising personnel.