Job Description
Job title: Process development technician II
Location: Andover, MA 01810
Duration:18+ Months
Pay rate: $22/hr. $27/hr.
Role Summary
The Senior Process Technician drives the execution of commercial, clinical, and/or development production according to standard operating procedures (SOPs) and the production schedule. This role involves working within interdisciplinary, self-directed teams to define and implement process improvements and to participate in process troubleshooting.
Role Responsibilities
- Execute manufacturing operations on the production floor, including buffer/media preparation, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and/or UF/DF skids with varying levels of automation.
- Follow and execute SOPs for unit operations, including but not limited to CIP, SIP, and sanitization.
- Support equipment commissioning, qualification, and validation, including issue resolution.
- Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
- Ensure right-first-time execution, timely review of daily documentation, and accurate data entry; monitor, identify, and communicate process and compliance trends in real time.
- Support audit leads during walkthroughs, GMP reviews, and observation improvements.
- Review and follow controlled documentation such as SOPs, manufacturing batch/formulation records, and forms.
- Collaborate with subject matter experts to support QTS investigations and CAPA implementation.
- Stay current with training programs related to manufacturing processes.
- Implement Lean Manufacturing, sustainability, and operational excellence initiatives to drive continuous improvement.
- Collaborate with cross-functional teams to support manufacturing campaigns.
- Escalate issues appropriately when operations, personnel safety, equipment functionality, product supply, or quality compliance are at risk.
- Ensure work requests are generated when issues arise with manufacturing equipment.
- Use enterprise systems (e.g., SAP, LIMS, AMPS, PDOCS, QTS) to support manufacturing operations.
- Maintain production sustainability by ensuring inventory accuracy, reconciliation, and task prioritization to meet performance metrics.