Validation Engineer II-31623
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.
The mission of the Manufacturing Requalification Department is to provide documented evidence that the manufacturing equipment and systems involved in producing commercial drug products at the Allston Landing Facility are maintained in a validated state and comply with applicable global regulatory requirements. The department's scope of work includes the periodic requalification of CIP and SIP processes, autoclaves, temperature-controlled rooms and chambers, cleanrooms, utilities, and other equipment. The deliverables of the Manufacturing Requalification team include Requalification Quality Reviews, Protocols, and Final Reports. These documents are made available to world-wide regulatory agencies via inclusion within regulatory filings and during audits and inspections of the Allston Landing Facility.
The Validation Engineer II (VE-II) reports directly to a Requalification Manager. The VE-II will be responsible for performing validation in a GMP biotech manufacturing facility managing medium size validation projects and providing technical assistance to less experienced technicians/engineers.
Responsibilities include the development of validation plans for small to medium size validation projects, qualification and validation of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes. In addition, the Validation Engineer II participates in reviews of supporting quality systems to ensure equipment and processes remain in a state of control.
The successful candidate will be responsible for developing moderately complex protocols using a risk based approach that meets current regulatory requirements and industry practices.
The Validation Engineer II will also be responsible for reviewing and approving peer validation reports and presenting the validation approach and study results to peers and managers. This position requires availability during 2 nd or 3 rd shifts when necessary (typically 10-20% of the time). Some travelling may be involved.
Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio
- Engineering/science Bachelors degree with at least 7 years of experience in the industry (5 years validation) or equivalent experience.
- Working knowledge of GMPs
- Validation using risk based approach (FMEA, PHA, etc)
- Ability to read/interpret engineering drawings and design documents
- Knowledge of Validation Lifecycle Approach (e.g. ASTM E2500)
- Conducting statistical analysis of validation test results
- Proficient in use of GE/Kaye Validator 2000
- Excellent technical writing and verbal communication skills
Investigation/ troubleshooting validation problems
- Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements
SPECIAL WORKING CONDITIONS
During preparation, execution, and recovery of validation studies, the Validation Engineer II will be required to work on and around equipment. Free range of motion and the ability to lift 35 lbs. is required.
- The Validation Engineer II will be required to be gowning qualified for entry into controlled and/or aseptic process environments.
Job : Quality
Primary Location : United States-Massachusetts-Allston
Job Posting : Nov 8, 2012
Shift : Day Job
Job Type : Regular
Employee Status : Regular