Associate Process Engineer

Descripción del trabajo

Responsibilities (include but are not limited to):

• Hands on involvement to execute laboratory studies to support process improvements

• Perform laboratory studies in accordance with SOPs and batch records

• Maintain good documentation practices

• Review technical documents (batch records, SOPs, protocols & reports for equipment qualifications, comparability, and cell therapy manufacturing process validation)

• Support development studies for process characterization and validation studies

• Participate in the evaluation of new technology and process automation for introduction into GMP manufacturing

• Effectively & efficiently communicate laboratory procedures internally

Basic Qualifications

• BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 0 years of relevant experience or

• AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience or

• HS Diploma with 3 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred Qualifications:

• Knowledge of pharmaceutical manufacturing of biotechnology products and process development

• Strong written and verbal communication skills

• Experience with cell therapy products and cell culture or aseptic processing is a plus

• General knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices

• Participate in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives