Manufacturing Technician II; 3rd Shift

Position Summary

You will be responsible for leading and executing complex vaccine drug substance manufacturing operations while ensuring compliant, safe, and efficient production. Serve as a technical expert in assigned processes, providing on‑floor leadership, training, problem‑solving support, and continuous improvement. Partner with supervisors and cross‑functional teams to ensure consistent execution of manufacturing activities.

• Manufacturing Process Execution:

  Execute complex drug substance manufacturing operations, including reagent and buffer preparation (weighing, formulation, pH adjustment/titration, filtration, aliquoting) in accordance with approved batch records and SOPs.

  Operate and monitor automated process equipment (e.g., chromatography, filtration systems, mixers, pumps, meters, scales), ensuring safe, efficient, and compliant execution of manufacturing activities.

• Proficiency in Digital Tools:

  Utilize advanced digital systems (e.g., electronic batch records, SCADA) to ensure data integrity, monitor process trends, identify deviations, support review by exception manufacturing, and improve overall process outcomes.

• Bioburden Control:

  Adhere to GMP cleanroom requirements (Grade C/D/CNC gowning and flows) and perform or coordinate environmental monitoring, cleaning, and sanitization activities per approved procedures.

• Asset Care & Maintenance:

  Troubleshoot equipment issues, respond to alarms, recognize early signs of equipment deterioration, and escalate abnormal conditions in a timely manner.

  Document equipment status, abnormalities, and actions taken, and contribute to initiatives that improve equipment reliability and extend asset life cycle.

• Documentation & Compliance:

  Ensure accurate, contemporaneous GMP documentation; participate in authoring and revising manufacturing and support SOPs; recognize and report deviations and support investigations, root cause analysis, and CAPA development.

• Training & Team Leadership:

  Develop and deliver training materials, act as a qualified trainer, support onboarding and qualification of new team members, and provide on‑floor process leadership.

  Assist supervisors with daily operations and lead manufacturing activities in the supervisor's absence as required.

• Continuous Improvement:

  Participate in troubleshooting and continuous improvement initiatives, applying GPS standards (e.g., 5S, problem solving) to improve safety, quality, delivery, and efficiency.

• Bachelor's degree in biological sciences, chemistry, engineering, or a related technical field. Equivalent combinations of education and experience accepted; candidates without a degree may qualify if they have relevant GMP manufacturing experience (e.g., 3+ years in process operations, QC, or equipment maintenance) or professional certifications that show comparable technical depth.
• 1+ year of manufacturing or production experience.
• Experience in leadership in a GMP manufacturing environment.
• Experience in technical writing for GMP documentation (e.g., SOPs, MBRs, training materials), with working knowledge of GMP requirements.

• BS or BA in a biological or chemical science degree.
• Demonstrated experience authoring and maintaining technical documentation, including SOPs, work instructions, and training materials in a regulated environment.
• Proven experience providing on‑floor leadership and technical guidance within a GMP manufacturing setting.
• Ability to safely handle acids, bases, oxidizers, chemicals, and solvents in accordance with procedures and required PPE.
• Proficient in performing basic mathematical calculations and accurately measuring volume and weight.
• Demonstrated ability to follow detailed processing instructions and accurately document batch records and manufacturing data in compliance with GMP requirements.
• Strong working knowledge of GMP principles and applicable regulatory requirements, with experience applying them in daily manufacturing operations.
• Demonstrated experience using digital and automated tools to support manufacturing execution and improve operational outcomes.
• Ability to perform routine physical tasks and lift up to 40…