Senior Process Technician

Job Title: Senior Process Technician

Location: Andover MA

Workplace Type: Onsite role

Work Schedule: Monday to Friday

Duration: 8 months W2 Contract

No of roles : 2

POSITION SUMMARY

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.

JOB RESPONSIBILITIES

• 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/GMP100s 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.