Validation Manager

Acambis is a leading biotechnology company targeting infectious diseases with novel vaccines. Its headquarters are in Cambridge, UK, and it has operations in Cambridge and Canton, MA, and in Rockville, MD.

 

Acambis’ development-stage pipeline includes an investigational vaccine against Japanese encephalitis, ChimeriVax-JE, which is undergoing Phase 3 clinical testing, ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing and is the most advanced investigational vaccine against the West Nile virus, and the only vaccine in development against Clostridium difficile bacteria, a leading cause of hospital-acquired infections. Acambis is recognised internationally as the leading producer of smallpox vaccines, which it manufactures for emergency-use stockpiles for the US Government and other governments around the world.

 

Acambis is listed on the London Stock Exchange (ACM).

 

The Maryland location is looking for a Validation Manger. This position will manage the start-up, validation and annual requalification activities at the Acambis Fill & Finish Facility in Rockville, MD, plan and oversee the development and execution of protocols and the development of final reports.

 Job Responsibilities:Manages the development, implementation and execution for validation test procedures to ensure product(s) meet appropriate international regulatory agency validation requirements, internal company standards and current industry  practices.  Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements.Independently perform work required to validate filling and support equipment (Isolators, Filling Lines, Autoclaves, Depyro Oven/Tunnel, Lyophilizer), GMP utilities, control systems and processes including writing protocols and reports and coordinating test work with various departments.Responsible for managing, generating and approving qualification and validation protocols and final reports, change control requests and deviation resolution associated with computer systems, facilities, equipment, utilities, process and cleaning validation for a Sterile Fill Facility.Projects in the areas of aseptic and bulk filling operations, multi-product cleaning, sterilization, control systems validation.Statistical analysis of collected data.Review validation data for other validation staff.Supervise/train other validation personnel and/or technicians and oversee contract personnel.

 

 

The right individual needs a B.S. in engineering or related science, with a minimum of 8 years’ validation experience. Experience with Lyophilization, Isolators, Filling Lines, Autoclaves, Depyro Oven/Tunnel and programming and calibrations of Kaye recorders is required. Experience and knowledge of pharmaceutical HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing is very desirable. Must be able to work on multiple projects simultaneously and be able to work efficiently in project teams. In addition to an extensive technical knowledge base, the ideal candidate must have exceptional interpersonal, managerial and negotiation skills, be highly self-motivated, well organized, and be able to develop alternative solutions to validation issues Broad knowledge of standard pharmaceutical and biotech industry validation. Team building, critical analysis skills, conflict resolution and proven leadership skills required. Must be willing to travel and be flexible to work after hours and weekends.

 

 

CONTACT INFO:

 

Human Resources

Acambis Inc.

38 Sidney Street

Cambridge, MA  02139

E-mail:  careers@acambis.com

Interested applicants must apply on-line attaching a word document to your email submission

 Acambis Inc. provides a competitive salary and a full range of benefits.

We are proud to be an equal opportunity employer, dedicated to promoting a culturally diverse workplace