Production Technician II

Job Summary

POSITION SUMMARY

The Production Technician II is responsible for supporting operations by training and mentoring Production Operators (Filling and packaging) as well as providing input to the engineering, validation, and maintenance groups at the Wilson site. The Production Technician II serves as a subject matter expert (SME) for a specific process that should be focused on maximizing equipment performance. This individual may support new product introductions and technology transfers to the site.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Serves as a specialist for a specific equipment process in a production area

• Applies considerable operations knowledge to perform a broad range of tasks on the production floor.

• Safely operates equipment per procedures and guidelines.

• Applies judgement in resolving issues and/or making recommendations for various assignments.

• Trains and mentors new and existing personnel as required.

• Interfaces with other departments, contractors, and original equipment manufacturers (OEM) to support equipment troubleshooting and perform maintenance.

• Works with other departments to execute equipment qualification and verification, such as SAT, I/O checkout, and IOPQ, as needed.

• As equipment SME, provides input into the development of SOPs/documentation related to operations and other cGMP activities.

• Adheres to cGMP, CFR, and safety requirements to ensure packaging products meet quality standards and production requirements.

• Performs maintenance PMs on any equipment in the production area where they are SME

• Performs principal activities of a production operator

REQUIREMENTS

• High School Diploma/GED or equivalent

• Must have at least five years of experience working in a cGMP-regulated pharmaceutical or medical device setting with at least ten years of total manufacturing experience.

• Must have effective troubleshooting and problem-solving skills.

• Demonstrated experience following approved protocols and standard operating procedures (SOPs) and the ability to follow verbal and written instructions.

• Must be classified as a Qualified Trainer who has successfully trained other operators in the production area.

Preferred Skills:

• Successful completion of continuing education units (CEU) in fundamentals of GMP, pharmaceuticals, Bioworks, or related studies

• Experience with equipment qualifications (such as conducting FAT, SAT, and IOPQ) and new product introduction technology transfers

• Experience developing or supporting development of SOPs/documentation related to operations and other cGMP activities

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 match, and wellness program.

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.