Process Engineer

Description

• Execute assigned projects for the implementation of new processes and equipment, problem solving for existing processes, process optimization and process validation activities
• Operational readiness of manufacturing equipment and facilities for commercial manufacture
• Generate related documents including SOPs, Batch Documentation, Validation Plans, Protocols and Evaluations
• Provide technical and operational support to meet internal and external customer requirements
• Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing
• Other duties as assigned

Qualifications

• Must have a Bachelor’s Degree; Preferred fields of study, Engineering, Life Science or Pharmacy and 5+ years of relevant experience OR equivalent combination of education and experience
• Prior Clinical and Commercial Process Engineering experience is preferred
• Must have knowledge of cGMP’s and regulatory requirements
• Knowledge and understanding of US and EU requirements for manufacturing is preferred
• Must have proficiency in MS Office - Project, Word and Excel