Process Engineer (pharmaceutical- bioprocess manufacturing science and technology)

Italy  /  South Europe  /  Full Time

Required experience
-            Pharma GMPs main regulations knowledge with at least 8 years experience preferably in role of Manufacturing Science and Technology or Process Validation subject matter expert
-            Experience in manufacturing of complex pharmaceutical forms such as aseptic process of drug product, lyophilized products, biological products
-            Process Validation and Continuous Process Verification
-            Filter Validation
-            Single use manufacturing systems
-            Aseptic Manufacturing and Media simulation study
-            experience in Technology Transfer team (at least 3 years)
-            Experience in project management in Technology Transfer projects or similar context
-            Risk management
-            Documentation Management (SOPs, Specification, Records)
-            Deviations/Non-conformities management
-            Data integrity
-            use of statistical tools and software
Other Desired Experience:
-            experience in biotechnology/ biosimilar products (Cell and gene therapy;  Cell culture expansion, harvest, purification, formulation, fill and finish; Blood plasma fractionation and component purification)
-            experience in solid oral pharmaceutical forms
-            Product Quality review
-            Developing Validation / Verification Master Plans
-            Performing formal risk assessments / FMEA
-            Change Control
-            CAPA process
-            Identifying Critical Attributes and Critical Process Parameters
-            Commissioning and Qualification
-            Developing User Requirements
-            Schedule development and execution
-            Establishing metrics and leading team to achieve performance goals
-            Facilitating meetings
La selezione rispetta il principio delle pari opportunità (l. 903/77)



(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country