Manufacturing Technician 4 - Night Shift

The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO

1d•$31 - $47

About The Position

The Manufacturing Technician 4 – Night Shift at our St. Louis Cherokee site is a key role within our GMP Manufacturing. Expectations is to ensure “Compliance “and “Readiness” within our GMP Operations teams, enabling high manufacturing success. Standard operations involve facility preparations, on-the-floor formulations, automated/manual ultrafiltration, and chromatography. Job duties include: This role will support manufacturing operations 24/7, 12 hours shifts, 6:00pm – 6:30 am. Including a shift differential. Evaluate products according to established protocols and perform operations in support of the group and department. Safely perform operations to meet quality expectations. Safely and properly dispose cleaning and process waste per approved procedures. Maintain required training to perform tasks/assignments. Perform routine processes and unit operations. Buffer formulation, ultrafiltration, and chromatography are standard. Clean equipment and working areas during and after operations. Support functions of the facility (e.g., maintain equipment, prepare reagents, and restock supplies, waste disposal). Communicate the status of operations and convey concerns to the supervisor. Provide complete and accurate records consistent with quality guidelines. Utilize quality approved operating procedures and document activities with adherence to GDP standards. Ensure all applicable logbooks are completed as required by current procedures. Interact with other departments as needed and performs procedures independently and part of a team. Improve processes through application of experience and principles, in compliance with change control. Develop and assist in the implementation of process improvement, safety, quality, and 6S. Take action to resolve unsafe conditions.

Requirements

High school diploma or GED.
6 + months of experience working in a cGMP environment

Nice To Haves

cGMP experience
Prior experience in an API manufacturing environment
Strong mechanical aptitude
Demonstrated process improvement experience.
Familiarity with FDA, EMA, and other regulatory standards
Demonstrated knowledge and experience in various computer skills, including Windows (Word, Excel, PowerPoint, etc.

Responsibilities

Evaluate products according to established protocols and perform operations in support of the group and department.
Safely perform operations to meet quality expectations. Safely and properly dispose cleaning and process waste per approved procedures.
Maintain required training to perform tasks/assignments.
Perform routine processes and unit operations. Buffer formulation, ultrafiltration, and chromatography are standard.
Clean equipment and working areas during and after operations.
Support functions of the facility (e.g., maintain equipment, prepare reagents, and restock supplies, waste disposal).
Communicate the status of operations and convey concerns to the supervisor.
Provide complete and accurate records consistent with quality guidelines. Utilize quality approved operating procedures and document activities with adherence to GDP standards.
Ensure all applicable logbooks are completed as required by current procedures.
Interact with other departments as needed and performs procedures independently and part of a team.
Improve processes through application of experience and principles, in compliance with change control.
Develop and assist in the implementation of process improvement, safety, quality, and 6S.
Take action to resolve unsafe conditions.