Manufacturing Technician II; 3rd Shift

Job Title

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

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.
• 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.
• 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.
• 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.
• Ensure accurate, contemporaneous GMP documentation; participate in authoring and revising manufacturing and support SOPs; recognize and report deviations and support investigations, RCA, and CAPA development.
• 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.
• Participate in troubleshooting and continuous improvement initiatives, applying GPS standards (e.g., 5S, problem solving) to improve safety, quality, delivery, and efficiency.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree in biological sciences, chemistry, engineering, or a related technical field. Equivalent combinations of education and experience accepted; candidates without a degree (including associate degrees or partial college) may qualify if they can have relevant GMP manufacturing experience (for example, 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.

If you have the following characteristics, it would be a plus:

• 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 (e.g., fractions, percentages, significant figures) 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…