Manufacturing Tech I (1st Shfit)

Fresenius Kabi•Warrendale, PA

About The Position

The Manufacturing Technician I works in the LVP Service Depot area, assisting with the diagnosis and repair of medical devices in a cGMP environment. With direct supervision, the technician follows relevant departmental SOPs and accurately completes device history records (DHRs). The role supports daily operations such as staging service devices for decontamination, provisioning, and repair; inspecting, packaging, and labeling finished products; maintaining and operating production equipment; and handling parts and supply inventory. Work must be completed efficiently while adhering to applicable SOPs and cGMP requirements. The position also includes routine equipment maintenance, equipment cleaning and disinfection, assisting with process equipment assembly and disassembly, completing required documentation, and supporting continuous improvement and cross-training. The technician is expected to maintain training requirements, work safely, and carry out other reasonable duties assigned by supervision or management.

Requirements

GED or high school diploma required.
0 to 2 years of work experience.
Ability to frequently lift and move materials or objects up to 40 pounds.
Ability to distinguish and identify colors.
Three-dimensional vision.
Ability to judge distance and spatial relationships.
Quality-minded with excellent attention to detail.
Ability to work as a team player.
Excellent attendance and punctuality.
Ability to complete periods of standing, twisting, and lifting during the shift.

Nice To Haves

Experience in a regulated industry is preferred.
For internal applicants, one year of electro-mechanical assembler experience is preferred.

Responsibilities

Execute routine service depot operations.
Assist with diagnosis and repair of medical devices.
Stage service devices for decontamination, provisioning, and service repair according to SOPs.
Inspect, repair, package, and label finished medical devices and pre-production materials.
Manage parts and supply inventory.
Perform scheduled basic maintenance and maintain equipment in the working area.
Assist with assembly and disassembly of process equipment.
Clean and disinfect equipment according to SOPs and cGMPs.
Complete required documentation per order, including DHRs, clearly and accurately.
Follow applicable departmental SOPs and maintain knowledge of relevant procedures and policies.
Work efficiently while adhering to applicable SOPs.
Meet and maintain training requirements; learn other core skills and participate in cross-training.
Participate in continuous quality improvement and contribute ideas and suggestions.
Carry out work safely and notify management of safety issues and risks.
Provide an annual performance self-assessment on the development plan.
Attend meetings and workshops as needed.
Undertake other duties and reasonable work activities assigned by supervision or management.
Comply with relevant legal requirements, codes of conduct, ethical standards, and company Health, Safety, Environment, Energy, and Quality Management Systems.