Engineer, Validation I
Engineer, Validation I
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.
- Perform 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 re-qualifications.
- Coordinate testing schedule with impacted area managers and quality control based on project needs.
- Provide input to technical composition of standard operating procedures.
- Generate custom validation protocols, execute protocols and write final reports.
- Create department standard operating procedures.
- Investigate and troubleshoot validation problems.
- Participate in equipment failure investigations, corrective/preventive actions and equipment release.
- Play a lead role in the successful completion of project milestones and crucial technical tasks.
- Provide assistance with Calibration and Metrology liaison responsibilities as department needs require.
- Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.
- Review and approve validation documentation.
- Other duties as assigned.
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 work experience and 2+ years validation experience OR Master’s Degree and 1+ year validation experience.
- 1+ 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 and final reports and managing validation projects.
- Ability to read/interpret engineering drawings and design documents.
- Knowledge of risk management tools and techniques.
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.
- May be required to lift, push or pull 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.