Process& Development Engineer II

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VACANCY REFERENCE NUMBER 120021
 

Process& Development Engineer II

Location: United States : Birmingham, AL

Function: Engineering; Production & Technology

Career Level: Experienced professionals (2-5 years)

Legal Entity: Evonik Corporation

Business Line: Health Care

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

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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.).

This individual contributes to engineering aspects of product and process development as well as to process trouble-shooting and optimization using a methodological approach (e.g. risk assessment, root cause analysis, Quality by Design, Design for Six Sigma, Lean Six Sigma, etc.). This position can serve as the technical lead for internal and/or customer projects or sub-projects. In addition, the individual can train and support other engineers, scientists, laboratory technicians, and co-ops on equipment operation and usage.

RESPONSIBILITIES

• Provide engineering support for process development and optimization on customer projects
  • Support the design, procurement, and assembly of process equipment sets, and author and review process and equipment design documentation
  • Design and execute development batches in support of pharmaceutical formulation research and development, engineering design, development, and scale-up, and cGMP manufacturing operations
  • Maintain thorough and accurate research and laboratory documentation including experimental methods, observations, data, and results
  • Support and/or drive the following activities within the department:
    • Risk management (ICH Q10, safety and quality risks, FMEA, equipment risks, process risks)
    • Root cause analysis (ABS toolbox, Ishikawa, 5 Why) and identification of engineering and scientific solutions
    • Data collection, storage and statistical analysis of data (ANOVA, hypothesis testing, correlation and regression analysis) and identification of appropriate actions
    • Process design and improvement using QbD, LSS and DfSS principles (e.g. SIPOC, FMEA, criticality analysis)
    • Process GAP analysis and mitigation during process development and scale-up (e.g. mixing design, fluid transport, drying, etc.)
  • Interact and communicate effectively with project teams,  consultants, management, and clients
• Process and Equipment Improvement and Optimization
  • Actively seeking and identifying opportunities to improve processes, equipment designs, and procedures; takes corrective action independently
  • Recommends improvements in intra-departmental workflows, as required e.g. scale-up approach, development framework
  • Optimize development and production processes for both client projects and internal projects
  • Contributes actively to increase process understandings and process control improvements on projects and in general
  • Contribute to the development of novel and proprietary technologies, methods, and Intellectual Property.
• Leadership and training to advance internal projects and individuals
  • Train other department members on the usage of equipment, the development process, documentation and tools and methodology to support the development process
  • Lead internal projects (continuous improvement projects, I2P projects, engineering projects)
• Other Responsibilities
  • 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.
• A demonstrated ability to do the following for research activities of an appropriate scope and complexity:
  • Conduct assigned tasks independently with minimal supervision of senior staff; utilize experience, knowledge, and technical creativity to independently determine and develop processes to meet project goals and objectives and resolve technical challenges; work on multiple activities in parallel and multi-faceted research studies or programs with minimal supervision; may independently perform research and engineering tasks of suitable scope and complexity.
  • Capable of conducting engineering studies, data analysis, and creating technical reports and presentations.
• 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.
• Knowledge and capability to support and facilitate most of the following tasks:
  • Risk management
  • Root cause analysis
  • Data collection, storage and statistical analysis of data
  • Process design and improvement using QbD, LSS and DfSS principles
  • Process Mapping and Drawing
  • Equipment assembling and dissembling as well as process setup/build-up
  • GAP analysis and mitigation
  • Documentation pertaining to GMP manufacturing
  • Usage of core process equipment including cleaning, understanding of maintenance and calibration and the optimization of process equipment.
• Proficient in the use of word processing, spreadsheet and presentation software programs as well as statistical software experience and data analysis proficiency.
• Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or exposure to hazardous chemicals that could potentially affect the health of the employee.
• Effective written and verbal communication skills; ability to clearly and effectively communicate observations, results, and outcomes to management and clients
• Capable of performing research tasks of appropriate scope and complexity to achieve goals and objectives with consideration to budget and time schedules with minimal supervision.
• Ability to:
  • Perform work utilizing a computer for extended periods of time;
  • Sit for extended periods of time without being able to leave the work area;
  • Stand for extended periods of time without being able to leave the work area;
  • Grasp objects utilizing the fingers (fine motor manipulation);
  • Reach for objects above the head or below the waist;
  • Stoop or crouch by bending at the waist or by bending the legs;
  • Determine colors

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.

VACANCY REFERENCE NUMBER 120021

Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.