Manufacturing Technician Level I-III

Theradaptive•Frederick, MD

17d•Onsite

About The Position

The Manufacturing Technician is responsible for executing all production processes for Theradaptive’s medical devices in a cGMP-compliant environment. This role involves operating specialized equipment, performing aseptic techniques, and ensuring accurate documentation to support the manufacture of 100% on-time high-quality products. A combination of experience and education will help determine position hiring level.

Requirements

High school diploma or GED required.
Experience in pharmaceutical or biotech manufacturing preferred.
Knowledge of cGMP, FDA & other Regulatory agencies regulations.
Strong attention to detail and documentation accuracy.
Basic computer proficiency (e.g., MES, ERP systems, Microsoft Office).

Nice To Haves

Associate degree in Life Sciences or technical field preferred.

Responsibilities

Operate and maintain manufacturing equipment (e.g., Autoclaves, Glasswashers, Lyophilizers, Mixers, Analytical Balances & Scales, Biosafety Cabinets, Fume hoods, Peristaltic Pumps, etc.).
Perform aseptic processing and GMP area cleaning operations in compliance with cGMP and internal SOPs.
Ensure timely review and completion of batch documentation (batch records, SOPs, logbooks, protocols & reports).
Assist with all material ordering, restocking and disposal following FEFO and FIFO principles.
Prepare and handle raw materials, components, and solutions used in production.
Conduct in-process quality checks and report/document deviations.
Assist in equipment cleaning, sterilization, and routine maintenance.
Collaborate with Quality Assurance, R&D, MM, and MS&T teams to ensure process integrity and improvements.
Participate in investigations, CAPAs, and continuous improvement initiatives.
Ability to create, review, and implement OJT training for current and future processes.
Always perform and remain up to date in all assigned training.