Process Development Technician

Title:
Process Development Technician II

Location:
Andover, MA 01810

100% Onsite

Duration: 12 months contract

The Senior Process Technician drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Senior Process Technician will work on interdisciplinary self-directed teams, to define and implement process improvements
, participate in process troubleshooting.

• Executes manufacturing operations on the production floor for buffer/media make-up
  tanks
  , glass washers, autoclaves, bioreactors, filtration equipment,
  inoculum preparation
  , chromatography skids and/or UF/DF skids with varying levels of automation.
• Executes the execution of SOPs for unit operations including but not limited to,
  CIPs, SIPs, Sanitization
  , etc.
• Implements the execution and issue resolution associated with process equipment commissioning, qualification and validation.
• Drives troubleshooting, technical support/analysis and resolution of equipment,
  automation
  , and process issues on the manufacturing floor.
• Drives for Right first time execution, the timely review of daily documentation and executes data entry;
  Monitor, Identify and/or Communicate process and compliance trends in real time.
• Supports the assigned audit lead for walkthroughs/
  GMP
  100s and observation improvements.
• View Role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
• Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
• Responsible for remaining current and reviews curriculum for training programs in support of manufacturing processes.
• Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
• Collaborates with cross-functional manufacturing assets in support of manufacturing campaigns.
• Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
• Ensures work requests are generated when issues arise with manufacturing equipment.
• Proficient in enterprise systems to support manufacturing operations including but not limited to,
  SAP, LIMS, AMPS, PDOCS and/or QTS.
• Operates production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence.