Validation Engineer II

Validation Engineer II

POSITION SUMMARY

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 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, I.
• Develop and publish new validation project plans and protocols, execute protocols and write final reports with little to no supervision.
• Participate in equipment failure investigations, corrective/preventive actions and equipment release.  Provide final approval for equipment release.
• 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.
• 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 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 4+ years of validation experience.
• Master’s Degree or equivalent and 2+ years of validation experience.
• 3+ years of experienced with process, equipment, utility, and/or software validation in a GMP regulated environment.

 

Preferred Qualifications:

• 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.

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.

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