Lead and execute automation activities that support pilot-scale GMP manufacturing campaigns for bulk biologics, including vaccines and therapeutic proteins used in clinical development.
Locations (3)
West Point, Pennsylvania, United States
San Francisco, California, United States
Los Angeles, California, United States
Compensation
The salary range for the primary location of this role is: $117,000.00 - $184,200.00
Responsibilities
Provide technical leadership and ongoing support for facility automation systems.
Serve as the automation subject matter expert for GMP clinical manufacturing campaigns.
Lead and/or execute the integration, commissioning, qualification, and startup of new equipment and automation projects.
Author, review, and approve GMP documentation, including change controls, test protocols, SDLC documentation, SOPs, safety assessments, deviation investigations and corrective actions.
Senior Specialist - Biologics Pilot Plant Automation Engineer (On-site)
Lead and execute automation activities that support pilot-scale GMP manufacturing campaigns for bulk biologics, including vaccines and therapeutic proteins used in clinical development.
Compensation
The salary range for the primary location of this role is: $117,000.00 - $184,200.00
Responsibilities
Provide technical leadership and ongoing support for facility automation systems.
Serve as the automation subject matter expert for GMP clinical manufacturing campaigns.
Lead and/or execute the integration, commissioning, qualification, and startup of new equipment and automation projects.
Author, review, and approve GMP documentation, including: Change controls Test protocols SDLC documentation Standard Operating Procedures (SOPs) Safety assessments Deviation investigations and corrective actions
Lead maintenance, lifecycle management, and upgrade initiatives for automation systems.
Supports a wide range of pilot-scale food processing projects, including beverage manufacturing, product development trials, research projects, and small-scale production activities.
Responsibilities
Assist the Pilot Plant Manager with preparation for food processing projects, research trials, beverage production, and product development activities.
Set up, stage, and organize equipment, ingredients, packaging materials, tools, and supplies for pilot plant operations.
Assist with beverage manufacturing activities, including ingredient preparation, batching, filing, packaging, labeling, cleaning, and documentation.
Clean and sanitize equipment, utensils, work surfaces, floors, drains, and other pilot plant areas before, during, and after processing activities.
Assist with receiving, organizing, labeling, and storing ingredients, packaging materials, finished products, and research samples.
Requirements
Must be academically enrolled in a high school, community college, or university
Must be enrolled in an FST undergraduate degree program
Nice to have: problem solving
Nice to have: clear communication
Nice to have: demonstratable commitment to promoting and enhancing diversity
The Specialist, Engineering serves as a Tech Ops Engineer supporting FLEx Non-Sterile clinical manufacturing operations, focusing on equipment ownership, production readiness, and technical support.
Compensation
The salary range for the primary location of this role is $87,300.00 - $137,400.00
Responsibilities
Own one or more manufacturing equipment trains or technical capability areas within FLEx Non-Sterile operations.
Maintain equipment readiness through preventive action tracking, alarm and performance review, procedural updates, training support, and coordination of required maintenance or engineering work.
Serve as a technical point of contact for equipment operation, setup, changeover, cleaning, assembly, disassembly, and troubleshooting.
Coordinate with Process Engineering, Maintenance, Automation, Facilities, vendors, and other subject matter experts to resolve equipment and system issues.
Support equipment changes, automation or mechanical improvements, and change control activities in accordance with applicable procedures.
Supports the development, optimization, and commercialization of new products, processes, and technologies through pilot plant and manufacturing trials, acting as a critical link between R&D and Operations.
Senior Specialist - Biologics Pilot Plant Automation Engineer (On-site)Merck · West Point, US+2 more
Process Engineer'' · Florenceville-Bristol, Canada