Manufacturing Technician I

Fresenius Kabi•Warrendale, PA

7d•Onsite

About The Position

The Manufacturing Technician I assists in the production, diagnosis, and repair of medical devices in a cGMP environment. Candidates will possess a high level of attention to detail with the ability to multitask between multiple areas. With direct supervision, the Manufacturing Technician I is responsible for following all relevant departmental SOPs and accurately completing DHRs for each device. Responsible for assisting in the set-up of daily activities ranging from staging devices for production, maintenance and cleaning of equipment per Standard Operating Procedures, Inspecting, Packaging and Labeling of finished products. Maintains equipment, operates production equipment, handles parts and supply inventory per Standard Operating Procedures. Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires.

Requirements

GED/High School diploma required.
0 to 2 years’ work experience; experience in a regulated industry is preferred.
Internal applicants: 1 year of electro-mechanical assembler experience preferred
Ability to frequently lift/move materials and objects (up to 40 lbs).
Ability to distinguish and identify colors.
Three-dimensional vision.
Ability to judge distance and space relationships.
Quality minded and excellent attention to detail.
Willing to work as a team player.
Excellent attendance and punctuality.
Effective verbal and written communication skills.
Able to take direction and work on production requirements as needed (after training).
The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Nice To Haves

experience in a regulated industry is preferred
Internal applicants: 1 year of electro-mechanical assembler experience preferred

Responsibilities

Perform scheduled basic maintenance of equipment, as required.
Be able to complete periods of standing or twist and lift activities during job shift.
Assist in the assembly and disassembly of process equipment.
Meet and maintain training requirements.
Provide annual performance self-assessment on development plan.
Cleaning and disinfection of equipment per SOPs and cGMPs.
Works in time efficient manner while maintaining adherence to all applicable SOPs.
Be able to learn and be competent in other core skills related to department. Not all cores skills are required.
Be able to complete documentation clearly and concisely.
Frequently lifts and/or moves material and/or objects (up to 40 lbs)
Execution of routine production operations
Inspecting and repairing finished medical devices and pre-production materials
Inventory management
Continuous Improvement
Maintenance of equipment in working area
Carry out work in a safe manner, notifying management of safety issues and risks
Assumes other duties and responsibilities as directed by supervision
Participates in any and all reasonable work activities as assigned by management.
Participates in continuous quality improvement.
Contribute improvement ideas and suggestions.
Attend workshops as required; open to cross training and becoming multi-skilled.
Review and Completion of all required documentation per order
Participate in meetings as needed.
Maintain a current and comprehensive knowledge of relevant procedures and policies.
Compliance with relevant Acts, legal demands, code of conduct and ethical standards.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.