Location: Norton,MA, USA
Job Title: Clinical Manufacturing Technician
Contract Role which may lead to direct hire!
Position Overview:
Under direct supervision, the Clinical Manufacturing Technician will perform routine clinical manufacturing operations at the Manufacturing Facility, ensuring all activities are safe, efficient, and cGMP-compliant. This role involves the operation of production equipment, handling of materials, and completion of various tasks to support the manufacturing of clinical products. The successful candidate will be detail-oriented, possess mechanical and scientific aptitude, and work well in a team setting.
Key Responsibilities:
* Operate production equipment in accordance with Standard Operating Procedures (SOPs) for tasks such as weigh/dispense, solution preparation, equipment CIP/COP (Cleaning In Place/Cleaning Out of Place), and small parts cleaning.
* Stock materials in the manufacturing suites, ensuring a smooth flow of required items for production activities.
* Collaborate with cross-functional teams including Facilities, Quality Control (QC), Quality Assurance (QA), Materials Management, and Environmental Health and Safety (EHS) to ensure the accurate and timely completion of tasks.
* Document all work thoroughly and accurately in compliance with cGMP requirements and existing forms.
* Maintain a clean and compliant manufacturing environment, following all safety protocols and cleanroom requirements.
* Perform repetitive physical tasks as part of shift-based work in a classified cleanroom environment.
Required Qualifications:
* Experience: 3-6 years of relevant experience, with mechanical and scientific aptitude.
* Education: Bachelors Preferred but will consider Biotech Certificate or 2-year degree preferred, with at least 1+ year of industry experience.
* Strong attention to detail, particularly in operational tasks and documentation.
* Excellent communication skills and the ability to work collaboratively in a team setting.
* Strong time management and organizational skills.
* Ability to perform physically demanding tasks on a manufacturing shift schedule.
Work Environment:
* Cleanroom environment requiring adherence to stringent gowning and hygiene protocols.
* Physical demands include lifting, repetitive movements, and long periods of standing during shift work.
Preferred Qualifications:
* Previous experience in a clinical manufacturing or biotech environment.
* Familiarity with cleanroom procedures and cGMP standards.
Safety & Compliance:
This role requires strict adherence to safety protocols and compliance with cGMP and regulatory requirements. Maintaining a compliant, efficient, and effective production environment is essential.
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