Sterile Manufacturing Technician

Overview:


TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. The job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.


Position: Sterile Manufacturing Technician


Location: Plainville, MA - 02762


Duration: 12 Months


Job Type: Temporary Assignment


Work Type: Onsite


Shift: Day Shift

Training Schedule: Monday-Friday, 7:00 AM - 3:30 PM (approximately 2-3 months)

Post-Training Schedule: 2-2-3 shift, 7:00 AM - 7:00 PM (12-hour shifts)

Summary

This is a Formulation Technician II / Sterile Manufacturing Technician to support the site. This client site in Plainville, MA supports sterile pharmaceutical manufacturing operations, including formulation, filtration, aseptic processing, visual inspection, and other GMP-regulated activities. This role is responsible for independently performing sterile manufacturing operations while ensuring compliance with cGMP regulations, quality standards, and safety requirements. The ideal candidate will have hands-on GMP manufacturing experience and the ability to work in a fast-paced, highly regulated environment.

Responsibilities

• Perform sterile manufacturing operations, including formulation, filtration, and aseptic filling.
• Handle materials, perform line clearance, prepare equipment, and support manufacturing operations.
• Operate, monitor, and troubleshoot manufacturing equipment and automated systems.
• Execute weight and dispense activities, solution preparation, autoclave operations, visual inspections, and material transactions.
• Ensure compliance with cGMP regulations, Good Documentation Practices (GDP), and data integrity standards.
• Monitor manufacturing processes and identify opportunities to improve safety, quality, and operational efficiency.
• Support investigations, deviations, change controls, and corrective and preventive actions (CAPA).
• Assist with equipment qualification, validation, and continuous improvement initiatives.
• Cross-train across multiple manufacturing functions to support production needs.
• Maintain a safe and compliant work environment while following all site procedures and PPE requirements.

Required Skills:

• Associate's or Bachelor's degree in Life Sciences, Engineering, or a related field preferred.
• Relevant GMP manufacturing experience may be considered in place of a degree.
• Minimum 2 years of GMP manufacturing or related technical experience.
• Experience working in sterile manufacturing or pharmaceutical production is preferred.
• Working knowledge of cGMP manufacturing operations.
• Experience operating and troubleshooting manufacturing equipment.
• Familiarity with sterile manufacturing processes, including formulation, filtration, and aseptic filling.
• Strong documentation skills with knowledge of Good Documentation Practices (GDP).
• Excellent problem-solving and troubleshooting abilities.
• Ability to work across multiple manufacturing processes and adapt to changing production priorities.
• Strong verbal and written communication skills.
• Ability to work in cleanroom environments while following gowning and PPE requirements.
• Ability to stand, walk, bend frequently, and occasionally lift up to 25 lbs.
• Willingness to work non-standard hours as required.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.