Operations Specialist

Evonik•Birmingham, AL

11d•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 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. 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. 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. Your Application To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at https://careers.evonik.com. Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations. Your Talent Acquisition Manager: Kelvin Seals [C] Company is Evonik Corporation This is your opportunity to join a thriving global organization that combines cutting-edge science, technology and engineering with world-class business services to create solutions that answer real-world problems. If you join us, we’ll expect you to take ownership of your work, team up with other great minds, and add your name to creations that make a positive difference for generations. As one of the world leaders in specialty chemicals operating in more than 100 countries with over 32,000 employees, we need your diversity of thought to make us better. In return for your passion, initiative and creativity, you’ll enjoy opportunities to improve and to be respected for your contribution. Click here to learn more about Evonik from our employees

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.