TEMP Manufacturing Tech Il

TalentBurst•Burlington, MA

About The Position

The Manufacturing Tech performs manufacturing activities in a cleanroom environment, including kitting and measuring components or raw materials; preparing components and assembling device assemblies; preparing bulk drug formulations; and carrying out filling, filing, capping, crimping, packaging, labeling, and sampling operations. The role also includes visual inspections and in-process inspection of assemblies and finished products against specification criteria. The Manufacturing Tech documents work and enters data into materials requirement planning (MRP) systems, batch records (BRs), and device history records (DHRs). All activities must follow good documentation practices (GDP), current good manufacturing practices (cGMPs), and quality management system (QMS) requirements, including applicable medical device GMP requirements and documented protocols, specifications, work instructions, standard operating procedures, and engineering batches. The role maintains the cleanroom environment through gowning, room cleaning, and supply management; organizes and cleans work areas; performs basic calculations and data entry; assembles, disassembles, and cleans process equipment; and cleans, etches, passivates, assembles, and inspects components. The position may also perform validation and qualification activities, including IQ/OQ/PQ/PV, and other tasks as required.

Requirements

2–4 years of related experience in the medical device, pharmaceutical, and/or biotechnology industries, or an associate degree with less than 1 year of experience.

Nice To Haves

Experience working in and maintaining a cleanroom in accordance with GDP and cGMP standards is highly desirable.

Responsibilities

Perform kitting operations, including measuring components or raw materials.
Perform work activities under a microscope.
Prepare components and build device assemblies.
Prepare bulk drug formulations.
Perform filling, filing, capping, and crimping operations.
Perform packaging and labeling operations.
Perform sampling and visual inspections.
Perform in-process inspections of assemblies and finished products according to specification criteria.
Document activities and enter data into MRP systems, batch records, and device history records.
Carry out work in accordance with GDP, cGMPs, QMS, and applicable medical device GMP requirements.
Follow protocols, specifications, work instructions, standard operating procedures, batch records, device history records, and engineering batches.
Maintain the cleanroom environment, including gowning, room cleaning, and supplies.
Perform basic calculations and data entry.
Assemble, disassemble, and clean process equipment.
Clean, etch, passivate, assemble, and inspect components.
Organize and clean work areas.
Perform validation and qualification activities, including IQ/OQ/PQ/PV.
Perform additional tasks as required.