Senior Process Technician

Responsibilities

• Execute manufacturing operations on the production floor for various equipment including buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying levels of automation.
• Follow Standard Operating Procedures (SOPs) for unit operations such as CIPs, SIPs, Sanitization, etc.
• Implement process equipment commissioning, qualification, and validation activities, and resolve related issues.
• Drive troubleshooting and provide technical support for equipment, automation, and process issues on the manufacturing floor.
• Ensure right-first-time execution, review daily documentation, and perform data entry; monitor, identify, and communicate process and compliance trends in real time.
• Support audit activities including walkthroughs, GMP100s, and observation improvements.
• Manage controlled documentation such as SOPs, Manufacturing Batch/Formulation Records, and Forms.
• Collaborate with Subject Matter Experts in support of investigations and CAPA implementations.
• Remain current with training curricula related to manufacturing processes.
• Implement Lean Manufacturing, Sustainability, and Operational Excellence initiatives to promote continuous improvement.
• Work with cross-functional manufacturing teams to support manufacturing campaigns.
• Escalate issues related to operations, personnel safety, equipment, product supply, or quality compliance to management.
• Generate work requests for manufacturing equipment issues.
• Utilize enterprise systems such as SAP, LIMS, AMPS, PDOCS, and QTS to support manufacturing operations.
• Maintain inventory accuracy and reconcile tasks to support production sustainability metrics.

Requirements

• Must have knowledge of GMP procedures, SOP management, and manufacturing documentation
• Proficiency with enterprise systems like SAP, LIMS, and QTS is a plus
• Strong troubleshooting and technical support skills
• Able to work in a team environment and support continuous improvement initiatives
• Excellent communication and documentation skills

Skills

• System One, and its subsidiaries including Joulé and Mountain Ltd.

Benefits

• Health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan

Pay

$25-$28.12

Schedule

2nd shift