Process Engineer - Fermentation

Auxilium Pharmaceuticals, Inc. is seeking a Process Engineer for its Horsham, PA manufacturing facility.  This position is responsible for performing necessary fermentation and production support activitiies for the development, validation and cGMP manufacture of protein products.  Work in a hands-on capacity in the GMP fermentation and production support areas to manufacture AA4500 under cGMP's.

The Major Responsibility Areas for this position include:

·  Support fermentation process scale-up, cGMP manufacture and validation as required.

·  Work in hands-on capacity to operate fermenters, perform seed scale-up, sterilize equipment and prepare production media..

.·  Revise and review manufacturing and process equipment documentation

·  Support validation efforts and assist in the implementation of change controls associated with fermentation equipment, processes and utilities.

·  Assist in the resolution of manufacturing deviations / non-conformances..

·  As required, troubleshoot processes and equipment and assist with process with process and cleaning validation initiatives.

·  Ensure work in completed in compliance with approved SOP's, batch records and controlled documentation and all applicable regulations, safety policies and procedures are followed..

 

The Skills and Behaviors of the successful incumbent include:

·  Proven ability to work well with others and establish strong working relationship with Manufacturing, Quality and Validation.

·  Exhibits open and constructive communication style based on the need of the receiver and by using the appropriate communication method

·  Exhibits high degree of accuracy and attention to detail.

·  Innovative and efficient when solving problems, while considering possible implications of the decisions made.

 

·Training and Experience for the successful incumbent include:

·  BS/MS Biological Sciences, Biotechnology or Biochemical Engineering.

·  Minimum 3-5 years working in biopharmaceutical cGMP manufacturing environment.

·  Strong background in fermentation and process scale-up of proteins and enzymes required. 

·  Experience working with/or in commercial and/or clinical manufacturing groups..

·  Working knowledge of cGMP and equipment, cleaning and process validation practices for biop[harmaceutical products.

 

  Auxilium offers competitive salaries, an outstanding benefits package that includes health and welfare plans, 401(k) with match, flexible spending accounts, employee stock purchase plan, and wellness programs, and a professional and dynamic work environment.

 

Qualified, interested candidates should either use the Apply Now option on this site, or forward their resume, indicating position of interest, via hrdept@auxilium.com . or Fax: 484-321-5997.

 

Auxilium is an equal opportunity employer committed to providing a culturally diverse workplace.