Development Engineer II

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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This position is responsible for supporting the development of manufacturing processes for complex parenteral formulations through process design, equipment specification and procurement, and equipment and process qualification. This position provides technical support in developing and optimizing cGMP manufacturing operations for complex parenteral formulations, including providing engineering support for the safe handling of high potent active pharmaceutical ingredients, and is responsible for the preparation of process and equipment documentation (e.g. PFDs, URSs, EAFs, ETOPs, IQOQs, etc.).

Responsibilities

• Provide engineering support for process development and optimization on customer projects
• Process and Equipment Improvement and Optimization
• Leadership and training to advance internal projects and individuals
• Follow safety practices and procedures; use personal protection equipment (PPE) appropriate to the type of hazard and exposure potential. Actively participate in identifying and resolving safety issues
• Provide support for PHAs and proper process safety design
• Follow cGMP regulations and procedures; generate and maintain thorough and accurate documentation in support of cGMP regulated activities
• Identify continuous improvement opportunities in documentation, quality, safety and daily operations and execute tasks and/or projects on gap closure or improvements
• Maintain and increase current scientific knowledge through review of current scientific literature and develop appropriate ways, methods and tools to do so
  
  

Requirements

• Three (3) or more years of directly related experience in process development is required, pharmaceutical experience preferred, experience in aseptic pharmaceutical manufacturing or development is a plus.
• A minimum MS in a relevant engineering field (e.g. pharmaceutical engineering, chemical engineering); or a BS in a relevant technical field with a sufficiently demonstrated level of performance and capability, as determined by management.
• Knowledge of the scientific and engineering principles pertaining to and capable in the operation of standard laboratory, analytical, and/or processing and manufacturing equipment; examples include reactor handling, extruder design, pumps, agitator, instrumentation, data collection, pilot plant operations, etc.
• A good understanding and application of relevant scientific theories, principles, and methods; familiarity or general working knowledge of other related technical fields and applications as well as the capability to use and apply standard scientific procedures and techniques.
• Recognize unanticipated or adverse outcomes or deviations; able to use technical expertise, experience, and creativity to evaluate and identify causes of unanticipated or adverse outcomes or deviations and to propose corrective action or resolutions for problems of increasing complexity; able to take corrective action to resolve technical problems of suitable complexity with minimal supervision.
• Understanding of Lean/Six Sigma/QbD principles is preferred.
• Understanding of FDA/EU Regulatory Guidance Framework, Industry Best Practices and cGMPs
• Experience designing and conducting studies based on statistical Design of Experiments principles.
  
  

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