Manufacturing Technician

Manufacturing Technician Job Description

This role is responsible for manufacturing pharmaceutical and medical device assemblies in a regulated GMP environment. You will perform a variety of hands‑on manufacturing tasks, including preparation of solutions and production materials, operation of equipment, in‑process testing, and accurate documentation of all activities. Positions are available in both the Formulation Department and another solution‑preparation‑focused department, with work performed in cleanroom and manufacturing settings.

• Perform setup, verification, and teardown of manufacturing equipment before and after processing to ensure readiness and compliance.
• Prepare solutions and production materials, including weighing, mixing, heating, cooling, sampling, and filtration according to established procedures.
• Carry out manufacturing tasks such as fabrication, in‑process testing, and packaging of pharmaceutical assemblies and medical devices.
• Document production activities accurately and legibly in manufacturing lot history records and controlled batch documentation to maintain full traceability.
• Clean and maintain production equipment and production areas in accordance with GMP, sanitization, and safety requirements.
• Utilize pipettes, microbalances, and other laboratory tools to measure and handle materials with precision.
• Perform analysis of process and test data as needed and communicate findings to appropriate personnel.
• Formulate polymers and prepare spray coating formulations, including excipient and coating solutions, following detailed instructions.
• Set up coating machines, coat, inspect, and fold balloon catheters in line with defined quality specifications.
• Support the preparation, mixing, inspection, filtration, and documentation of solutions used in the production of drug‑loaded polymer microspheres.
• Operate mixers, jacketed tanks, temperature control units (TCU), peristaltic pumps, ultrasonic baths, bottle rollers, and balances safely and effectively.
• Perform in‑process inspections and environmental controls to verify that products and processes meet defined standards.
• Follow line clearance, cleaning, personal protective equipment (PPE), and safety requirements at all times.
• Escalate deviations, out‑of‑specification results, or unusual observations to supervision or engineering promptly.
• Operate machinery to produce medical devices that meet all required specifications and quality standards.
• Follow detailed manufacturing instructions and update relevant job documentation accurately for complete traceability.
• Perform product packing and prepare items for sterilization according to established procedures.
• Inspect products using a microscope and other inspection tools to identify defects and verify quality.
• Troubleshoot basic product and process‑related issues and collaborate with supervision or engineering to resolve them.
• Work with toxic chemicals and powders in a laboratory and cleanroom environment while adhering to strict safety and handling procedures.

• Minimum of a High School Diploma or GED.
• At least 2 years of related experience in pharmaceutical or medical device manufacturing for roles in the Formulation Department.
• Alternatively, at least 2 years of experience working in a laboratory environment, including basic math skills and comfort working with toxic chemicals, for roles in the solution‑preparation‑focused department.
• Experience working with chemicals, including safe handling of toxic chemicals and powders.
• 2+ years of experience in medical device or pharmaceutical manufacturing for Formulation Department roles.
• Hands‑on experience in cleanroom or controlled manufacturing environments.
• Familiarity with GMP (Good Manufacturing Practices) and adherence to SOPs (Standard Operating Procedures).
• Ability to follow aseptic techniques and aseptic handling practices as required.
• Experience with assembly, packaging, and sanitization processes in a regulated environment.
• Ability to accurately complete batch records, manufacturing lot history records, and other controlled documentation.
• Competence in using basic laboratory equipment such as pipettes, balances, and…