Validation Specialist I-32460
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Validation Specialist I
We currently have an openng for a Validation Specialist I in our Cambridge Biosurgery site. 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 requalifications.
- 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.
- Contribute to 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.
1-2 years experience with process, equipment, utility and/or software validation in a GMP regulated environment
- Bachelor's Degree or equivalent and 2-5 years validation experience
- Masters Degree and 0-2 years validation experience
Job : Quality
- 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
Primary Location : United States-Massachusetts-Cambridge
Job Posting : Feb 28, 2013
Shift : Day Job
Job Type : Regular
Employee Status : Regular