Manufacturing Technician

Manufacturing Technician

This role is responsible for manufacturing pharmaceutical and medical device assemblies in a regulated GMP environment. The position supports multiple departments, including Formulation, a solutions-focused department, and a Vialing department, and involves tasks such as solution preparation, equipment setup and operation, in-process testing, packaging, and accurate documentation of manufacturing activities.

Responsibilities

• Perform setup, verification, and teardown of manufacturing equipment before and after processing to ensure proper operation and compliance with procedures.
• Prepare solutions and production materials, including weighing, mixing, heating, cooling, sampling, filtration, and handling of raw materials according to detailed instructions.
• Execute manufacturing tasks such as fabrication, in-process testing, packaging, and sterilization preparation of pharmaceutical and medical device products.
• Formulate polymers and spray coating formulations, including preparation of excipient and spray coating solutions used in coating processes.
• Set up coating machines and coat, inspect, and fold balloon catheters and other delicate medical device components with precision and care.
• Support the preparation, mixing, inspection, filtration, and documentation of solutions used in the production of drug-loaded polymer microspheres.
• Operate a variety of equipment such as mixers, jacketed tanks, temperature control units (TCU), peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, micro balances, and coating machines.
• Perform in-process inspections and environmental controls to ensure products and processes meet defined specifications and quality standards.
• Conduct basic visual inspections using microscopes or magnification tools to verify product quality and identify defects.
• Document production activities accurately in manufacturing lot history records, batch records, and controlled documentation, following Good Documentation Practices (GDP).
• Follow detailed work instructions, standard operating procedures (SOPs), cleanroom practices, and line clearance requirements to maintain compliance with GMP and company standards.
• Clean and maintain production equipment, workstations, tools, and production areas in accordance with 5S, sanitization, and GMP requirements.
• Utilize pipettes and micro weight equipment to perform precise measurements and support accurate formulation activities.
• Perform analysis of data as needed to support process monitoring, troubleshooting, and continuous improvement efforts.
• Follow personal protective equipment (PPE) and safety requirements, including working safely with toxic chemicals and powders in a laboratory and cleanroom environment.
• Escalate deviations, out-of-specification results, equipment malfunctions, or material shortages promptly to supervision or engineering for timely resolution.
• Operate machinery to produce medical devices that meet defined specifications, following manufacturing instructions and updating job documentation accurately for traceability.
• Participate in basic problem-solving and continuous-improvement activities to enhance product quality, process efficiency, and safety.
• Support adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), aseptic techniques, and all company safety procedures across all assigned operations.

Essential Skills

• Experience working in a cleanroom or regulated manufacturing environment, preferably in pharmaceutical or medical device production.
• Minimum of 2 years of medical device or pharmaceutical manufacturing experience for roles in the Formulation Department.
• Minimum of 2 years of experience working with chemicals in a laboratory or manufacturing setting for roles in the solutions-focused department, including comfort working with toxic chemicals and powders.
• Minimum of 1 year of related experience in pharmaceutical or medical device manufacturing for roles in the Vialing Department.
• Demonstrated ability to follow GMP, GDP, SOPs, aseptic techniques, and cleanroom practices consistently.
• Proficiency in preparing solutions, including weighing, mixing, heating, cooling, sampling, and filtration, with strong attention to accuracy and detail.
• Ability to operate manufacturing and laboratory equipment such as mixers, jacketed tanks, TCUs, peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, micro balances, and coating machines.
• Skill in handling delicate medical device components and performing inspections using microscopes or magnification tools.
• Strong documentation skills, including accurate completion of batch records, lot history records, and other controlled documents.
• Basic math skills and the ability to perform calculations required for solution preparation, measurements, and data recording.
• Ability to troubleshoot product and process-related issues and escalate concerns appropriately.
• Commitment to safety, including adherence to PPE requirements and safe handling of chemicals and equipment.

Additional Skills & Qualifications

• High School Diploma or GED.
• For Formulation Department roles: at least 2 years of related experience in pharmaceutical or medical device manufacturing.
• For solutions-focused department roles: at least 2 years of experience working in a laboratory environment, with basic math skills and comfort working with toxic chemicals.
• For Vialing Department roles: at least 1 year of related experience in pharmaceutical or medical device manufacturing.
• Experience with medical device and pharmaceutical assembly, packaging, and sterilization preparation.
• Familiarity with aseptic techniques, aseptic handling, and sanitization procedures in a cleanroom environment.
• Experience working with chemical processes, polymers, and spray coating formulations.
• Ability to read, understand, and follow detailed work instructions, SOPs, and manufacturing instructions.
• Strong organizational skills and the ability to maintain a clean, orderly, and compliant work area.
• Comfort working across different shifts, including early morning, mid-day, and occasional Saturday work as needed.

Why Work Here?

• The organization focuses on developing advanced drug-device combination products that address critical and unmet medical needs, offering the opportunity to contribute to next-generation healthcare solutions.
• Team members work within a global environment that values innovation, quality, and continuous improvement, with operations spanning multiple international locations.
• The culture emphasizes collaboration, safety, and professional growth, providing a setting where employees can build their skills while supporting life-changing medical technologies.

Work Environment

• The role is based in a cleanroom and manufacturing environment that follows strict GMP, GDP, aseptic, and safety standards.
• Work is performed in designated departments with defined shift schedules, such as 11:00 a.m.7:30 p.m. with occasional Saturdays for the Formulation Department, early morning shifts such as 5:00 a.m.1:30 p.m. on certain weekdays with a mid-day shift on others for the Solutions-Focused Department, and 6:00 a.m.2:30 p.m. with some Saturdays as needed for the Vialing Department.
• Employees work with mixers, jacketed tanks, temperature control units, peristaltic pumps, ultrasonic baths, bottle rollers, balances, pipettes, micro balances, coating machines, and other production equipment.
• The environment involves handling chemicals, polymers, toxic powders, and delicate medical device components in a cleanroom setting, with required use of PPE and adherence to line clearance, cleaning, and sanitization procedures.
• Workstations and production areas follow 5S principles and are maintained to high standards of cleanliness and organization to support product quality and regulatory compliance.