Validation Engineer II – Genzyme – Framingham, MA, USA
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.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.
JOB DESCRIPTION – Validation Engineer II
To provide validation services and expertise in support of local and global operations and to ensure harmonized validation policies across sites that are in compliance with industry practices and regulatory requirements.
Areas of support: Corporate Validation Standards and Practices, CMO Validation, Global Cold Chain Validation, On-site Resource Support for Northborough, Waltham and select Framingham facilities / areas
- Assure compliance of validated systems for GMP and GLP facilities.
- Ensure adherence to worldwide regulatory requirements and corporate standards.
- Write and execute validation protocols (DQ, IQ,OQ,PQ,RQ, PV) with little to no supervision as well as to write comprehensive final reports containing thorough resolution of protocol discrepancies. Temperature mapping protocols are a primary focus.
- Provides technical assistance to less experienced technicians/engineers.
- Work as part of a team to ensure that validation activities are completed on time and correctly.
- Ensure assigned requalifications are completed on time.
- Bachelor’s degree and 5+ years (or High School degree with 10+ years’ experience) of hands-on validation experience in Biotech, Pharmaceuticals or Medical Device operations, including protocol development and field execution.
- Working knowledge of applicable US and worldwide regulatory requirements (e.g. GMP, GDP).
- Ability to develop protocols using design documents and user requirements.
- Ability to manage small to medium size projects.
- Ability to perform basic statistical analysis of validation test results.
- Strong technical writing and verbal communication skills.
- Proficient in use of GE/Kaye Validator 2000 and/or wireless data logging systems
- Ability to read/interpret engineering drawings (e.g. P&IDs, PFD’s)
- Investigation/troubleshooting system failures. #LI-GZ