Manufacturing Technician I

Fresenius Kabi USA; Warrendale (Allegheny County); On-site; USD 42,000 - 61,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA is seeking a Manufacturing Technician I to assist in production, diagnosis, and repair of medical devices in a cGMP environment. The role emphasizes attention to detail, following SOPs, and accurate DHR completion, with daily activities spanning device staging, equipment maintenance, cleaning, inspection, packaging, and labeling.

Candidates must be authorized to work in the United States without sponsorship.

Qualifications

• 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).
• Excellent attendance and punctuality.
• Effective verbal and written communication skills.

Responsibilities

• Perform scheduled basic maintenance of equipment, as required.
• Assist in assembly and disassembly of process equipment; meet and maintain training requirements.
• Inspecting and repairing finished medical devices and pre-production materials.
• Inventory management and documentation per SOPs.
• Maintain equipment and perform cleaning per SOPs and cGMPs.
• Capacity to learn and be competent in other core skills related to the department.

Skills

Attention to detail

English proficiency

Team player

Communication skills

Ability to lift 40 lbs

Electro-mechanical assembly (internal)

Education

GED or High School diploma

Job description

Job Summary

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.

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)

Key Responsibilities

• 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.

Continuous Improvement

• Participates in continuous quality improvement.
• Contribute improvement ideas and suggestions.
• Attend workshops as required; open to cross training and becoming multi-skilled.

Administration

• Review and Completion of all required documentation per order
• Participate in meetings as needed.

Knowledge and Compliance

• 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.

Requirements

• The Company’s primary business language is English. 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.
• 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).

Additional Information

• We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.