Filling Engineer

Filling Engineer 

Reference #: MON-03989
Ohio Manufacturing Facility

Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates. Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we’re always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.

Currently, we have a great opportunity for a self motivated, hands-on, process oriented and a technical leader to join our team.

This position is responsible for the design, construction, start-up, commissioning, validation, and manufacturing operation of a new fully integrated pharmaceutical filling suite.

Specifically, you will:

• Direct vendors, generate URS documents, generate and/or approve design specifications, commissioning and validation documents
• Assume responsibility for start-up, commissioning and qualification of equipment
• Participate in design review meetings with vendors and contractors
• Witness and assist FAT at vendor sites and SAT onsite
• Manage vendor and contractor activities during design, fabrication, installation, commission and qualification activities
• Interface and coordinate with Project Management, corporate Engineering, construction manager and Ohio site staff to ensure the manufacturing filling and components processing suite meets user and technical requirements.

This position requires:

• A BS/MS in Mechanical Engineering, Chemical Engineering or equivalent
• 5+ years of relevant industry experience
• At least 2 years of experience in cGMP pharmaceutical manufacturing environment
• Knowledge of FDA regulations and guidelines
• Experience with one or more of the following: aseptic filling line equipment, sterile component preparation equipment, packaging equipment, sterilizers and/or automated inspection equipment
• Understanding of supporting plant and clean utility systems
• Excellent organizational and written/verbal communication skills
• Experience working on cross functional teams
• The ability to travel
• Knowledge of clean rooms environments, HEPA filtration, project management and project planning, SCADA/PLC automation systems and automated material handling systems preferred.

By “Challenging Science,� Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin’s approach and dedication are rooted in the belief that we will be “Changing Lives� for millions of people. At Amylin, you’ll have the chance to truly make a difference in people’s lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.



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AMYLIN
Challenging Science. Changing Lives.