Operations Specialist

Evonik•Birmingham, AL

4d•Hybrid

About The Position

What we offer Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us. Click on the link below to learn what our employees have to say about Evonik: https ://careers.evonik.com/en/about/meet-the-team/ Controls or operates machinery or equipment to assist with manufacturing, packaging, and other steps along a production line. May be expected to handle heavy machinery

Requirements

BS Degree in science or engineering is preferred.
1-3 years relevant industry experience in pharmaceutical and/or chemical industry with production/manufacturing experience.
Competent level understanding of operational requirements for cleanrooms in FDA regulated environment.
Detailed knowledge of the scientific principles pertaining to standard processing and manufacturing equipment including, but not limited to, extruders, pumps, stirred-reactors, filtration devices, hot oil systems, cooling systems, grinding mills, pelletizers, fillers, etc.
Excellent written, verbal, organizational, and people skills
Excellent leadership skills.
Ability to multi-task and manage complicated, dynamic manufacturing activities in multiple locations on time and on/under budget while also managing other job-related tasks/activities.
Ability to interact and communicate effectively with senior management regarding aspects of past, present and future programs/projects.

Responsibilities

Lead manufacturing safety, training, environmental compliance, and housekeeping efforts while ensuring team accountability.
Ensure regulatory and SOP compliance (FDA, EMA, IPEC, ISO, GMP) through oversight, training, and documentation support.
Drive continuous improvement initiatives in GMP documentation, training effectiveness, deviation reduction, and product release processes.
Lead batch readiness and quality meetings , including BMA Batch Preparedness and Trackwise meetings, with documentation tracking and follow-up.
Manage and report departmental metrics , including data entry, trending, fault log oversight, and manufacturing cost tracking in SAP.
Support operational improvement projects and technical initiatives , partnering with business leaders to enhance manufacturing capabilities.
Assist with process validation, transfers, and new product introductions , including CMO projects, RESOMER® products, and medical device integration.
Support cleanroom process integration and validation activities , including PSSR coordination, batch record development, and execution of IOQ validations.