Operations Technician

The operations technician will create, edit, and review documents and provide 24/7 technical coverage during the execution of the documents as necessary to support manufacturing. This position plays a critical role in the organization by authoring and editing master production records (MPRs) for setups and clean‑downs. The ability to author MPRs for efficiency, flexibility, and modularity will support efforts at the site to decrease rig downtime during changeovers and ensure OTIF goals are met in production.

Responsibilities

Provide 24/7 technical coverage for execution of setup and cleaning processes.

Write/edit master production records (MPRs) for set‑ups and clean‑downs.

Write additional information
ote (AIN) pages.

Perform field verifications to ensure that documents are accurate and executable.

Author cleaning risk assessments, validation protocols, cleaning summary and interim reports, and other validation supporting documentation.

Route documents in Regulus for review and approval.

Develop and maintain process PWISIS and BOM’s for setups and cleandown processes.

Generate, investigate and manage the approval and closure of deviations in the Trackwise System.

Own and complete change and deviation action assignments.

Author pressure checks.

Maintain operations execution performance capability by keeping qualifications and training current in at least one small molecule operating area. There may be times that short term production floor assignments are required to meet business needs.

Prepare swab kits for production buildings.

Develop cleaning process strategies.

Assist as needed in the planning and coordination of changeovers (cleandown and/or setup) in the plant.

Write and update protocols/procedures for new operations and equipment.

Represent the department on technical teams and projects.

Drive continuous improvement.

Provide feedback and improvement ideas to area management and technical support staff.

Drive improvements to reduce process changeover times and improve sustainability.

Write/edit patrol lists.

Requirements

High School Diploma.

Strong oral, written, and interpersonal communication skills with the ability to communicate clearly and accurately.

Ability to write and revise new and established controlled documents (manufacturing documents, procedures, job aids, etc.) with the required amount of detail.

Self‑directed, self‑managed, reliable, and capable of success with minimal supervision.

Project management skills – complete assigned tasks on time with the ability to prioritize in an environment of competing demands.

Strong technical problem‑solving ability.

Proficient keyboarding skills and experience with MS Word, Excel, and Visio.

Preferred experience in TrackWise and Regulus.

Clear understanding of GMP requirements and how they apply to our business.

Familiarity with the operation of production equipment.

Ability to work in a heavily regulated environment.

Ability to influence groups without having supervisory responsibility.

High school diploma or equivalent.

For the Operations Specialist (26N), minimum of 10 years of experience as a production operator or proficiency in the Operations Technician role plus proven capability of Operations Specialist skills and behaviors preferred.

The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.

#J-18808-Ljbffr