Manufacturing Specialist

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.

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https://careers.evonik.com/en/about/meet-the-team/

The Manufacturing Specialist acts as primary production process owner and subject matter expert (SME) for assigned manufacturing area(s) which include manufacturing processes in Parenteral Commercial Manufacturing Operations (CMO). Responsibilities may include unit operations, processes, and combinations of both.

RESPONSIBILITIES

• Responsibilities include cGMP process and batch execution in clean room manufacturing activities.
• Responsible for manufacturing related regulatory compliance (FDA, EMA, IPEC, ISO, etc.), adherence to company and departmental goals and objectives, GDP activities, maintenance outages, etc., training of front line personnel, interaction with other department leads and company management, CMO readiness and process transfer, Leadership and accountability in the areas of manufacturing safety, training, environmental compliance, and area housekeeping.
• Development of new training materials and maintaining current curricula for operational staff.
• May require additional support activities for interaction with clients and / or client representatives (site tours, face-to-face client meetings). Support, training, and accountability in the area of regulatory compliance (FDA, EMA, IPEC, ISO, etc.) and standard operating procedures.
• Manufacturing specialist is responsible for workcell / shift execution readiness including but not limited to batch ticket readiness, change control, document revision, material issuance, process order control, batch issuance; in process real time process monitoring, batch ticket review, process performance trending / reporting; post process continuous improvement through after-action review and other process improvement duties as needed to achieve functional objective and targets.
• Seek out and identify opportunities for improvement in the areas of GMP document management, training, execution, deviation causal factors, and product release.
• Contribute to Departmental metrics data entry; Area and unit operation process performance trending/reporting.
• Develop and lead manufacturing initiatives such as operational improvement projects, and technical/operational capability support to business line and product line leaders.
• Own and lead customer process validation efforts from concept to closure.
• Own and sustain process transfers and customer product lifecycle.
• Own and lead integration efforts of new processes into the cleanroom.
• Execution of validation IOQ’s, PPQ, or other validations with minimal assistance from process engineering and validation.

REQUIREMENTS

• BA/BS Degree in STEM subject (0-2 years experience) preferred.
• Relevant industry experience in pharmaceutical and/or chemical industry with production/manufacturing experience is required for higher level Specialist assignments.
• Competent level understanding of operational requirements for cleanrooms in highly regulated environment pharmaceutical.
• 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 production operators and senior management regarding aspects of past, present and future manufacturing unit operations and improvements.

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.

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