Process Technician - Filling (Night Shift)

Role Summary

Process Technician - Filling (Night Shift) responsible for the safe and compliant daily execution of filling activities to produce pre-filled syringes at Lilly’s Durham, NC site. The role requires adherence to GMPs, collaboration with a team, and flexibility to support multiple filling lines, including PFS9 isolator startup.

Responsibilities

• Adhere to RTP Plant safety policies and procedures, contribute to a safe work environment.
• Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.
• Support leadership on manufacturing floor by ensuring high level of safety, quality, and productivity to maintain reliable supply of products to patients.
• Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
• Execute documentation of process tasks adhering to ALCOA+ principles.
• Execute material movement, cleaning, part install, line monitoring, navigate electronic systems to complete tasks, and any task designated by the supervisor.
• Stand for extended hours and lift material overhead to support isolator activities.
• Support PFS9 activities in commissioning and qualification and to commercial production.

Qualifications

• High School Diploma or equivalent
• Ability to effectively communicate (written and verbal) and apply logic to problem solve unexpected events.
• Ability to work 12-hour shifts on days (2-2-3 schedule) and work overtime as required and planned by the supervisor.
• Ability to gown in a classified space, work in restrictive gowning/environment.
• Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)
• Basic computer skills for electronic batch record interface and training execution/documentation
• BioWorks Certificate or equivalent experience
• Knowledge of Current Good Manufacturing Practices (CGMPs)

Skills

• Scientific/technical degrees or certifications
• Previous experience with pre-filled syringe (PFS) technology, utilizing solution filling equipment and/or isolator technology
• Previous experience with Manufacturing Execution Systems and electronic batch release
• Knowledge of lean manufacturing principles

Education

• High School Diploma or equivalent

Additional Requirements

• Ability to travel for training, potential travel is <5% of the year
• Stand for extended hours and lift material overhead to support isolator activities