Manufacturing Technician II (3rd Shift)

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, RCA, 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.

Why You?

Basic Qualification
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.

Preferred Qualification
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 in daily manufacturing operations.

• Demonstrated experience using digital and automated tools (e.g., electronic batch records, automation systems, analytics) to support manufacturing execution and improve operational outcomes.

• Ability to perform routine physical tasks and lift up to 40 pounds.

• Willingness and ability to work first shift on-site; this role is not hybrid or remote.

• Available to work on weekends, holidays, and extra hours when needed.

• Effective verbal and written communication for all organizational levels.

• Demonstrated digital agility, with the ability to quickly learn and effectively use manufacturing and business systems (e.g., SAP, SCADA, MES, Microsoft Office) to support GMP operations.

• Experienced with cleanroom operations with equipment such as filtration systems, chromatography, mixers, meters, scales, pumps, and parts washers.

Work arrangement and physical expectations

• This role is on-site in the United States. Hybrid or remote work is not available. Multiple shift available. 3rd shift eligible for 15% shift differential.

• You will work in a temperature-controlled manufacturing area with possible exposure to noise and moving mechanical parts.

• You must wear required personal protective equipment.

• The role includes standing, walking and physical tasks throughout the shift. Overtime may be required.

What we value
We welcome people from all backgrounds and support an environment of inclusion. We place safety and quality first. We support learning and career growth and encourage open collaboration. If you enjoy hands-on technical work and helping teams improve, we encourage you to apply.

Ready to apply?
If this role feels like the next step for you, please apply now. Share your resume and a short note about what you will bring to the team. We look forward to hearing from you.

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