Validation Engineer II
Company: Vericel Corporation
Posted on: September 17, 2023
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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. Position Summary: Responsible for
performing validation projects in a GMP biotech manufacturing
facility. ESSENTIAL FUNCTIONS Core Responsibilities:
- Master core responsibilities of an Engineer, Validation,
- Develop and publish new validation project plans and protocols,
execute protocols and write final reports with little to no
- Participate in equipment failure investigations,
corrective/preventive actions and equipment release. Provide final
approval for equipment release.
- Provide technical assistance to less experienced
- Routine and effective communication with immediate supervisor
and other personnel within the group in addition to outside the
- Review and approve validation and calibration
- Other duties as assigned. QUALIFICATIONS, EDUCATION AND
EXPERIENCE 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 all of our products and services. This
- 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
- Constantly striving to make Vericel a great place to work, and
a company respected for the quality of its people and
- 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 4+ years of validation
- Master's Degree or equivalent and 2+ years of validation
- 3+ 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
- Working knowledge of GMPs.
- Excellent technical writing and verbal communication
- 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
- Experience with writing validation protocols, project plans and
final reports and managing validation projects.
- Ability to read/interpret engineering drawings and design
- Knowledge of risk management tools and techniques.
- Knowledge of international regulatory requirements. 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
- May be required to lift, push or pull up to 40 lbs.
Keywords: Vericel Corporation, Cambridge , Validation Engineer II, Engineering , Cambridge, Massachusetts
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