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Engineer I - Development

Date: Sep 14, 2021

Location: Birmingham, AL, US

Company: Evonik Industries AG

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VACANCY REFERENCE NUMBER 149902
 

Engineer I - Development

 

Location: United States : Birmingham, AL

Function: Engineering

Career Level: Graduates (< 2 years)

Legal Entity: Evonik Nutrition & Care GmbH

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.

Click here to learn more about Evonik from our employees

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 supporting 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 could provide or support engineering solutions and applications of engineering principles to support customer projects and internal intellectual property projects.

 

RESPONSIBILITIES

  • Provide engineering support for process development and optimization on customer projects
    • Design and execute development batches in support of pharmaceutical formulation research and development, engineering design, development, and scale-up, and cGMP manufacturing operations
    • Support the design, procurement, and assembly of process equipment sets, and support the authorship and reviewing of the process and equipment design documentation
    • Maintain thorough and accurate research and laboratory documentation including experimental methods, observations, data, and results (GDP)
    • Learns, supports and/or drives one to multiple of 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
    • Recommends improvements in intra-departmental workflows, as required e.g. scale-up approach, development framework
    • Contributes actively to increase process understandings and process control improvements on projects and in general
    • 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
    • Contribute to the development of novel and proprietary technologies, methods, and Intellectual Property.
  • 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
    • Contribute to safety, quality, and appearance of laboratory and other working spaces
    • Ensure training and growth progression by self-studies, OJTs, instructor led training, and other development resources
 

REQUIREMENTS

  • 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.
  • Directly related experience in process development from small scale to pilot scale and commercial scale is preferred, pharmaceutical experience preferred, experience in aseptic pharmaceutical manufacturing or development is a plus as well as knowledge about drug delivery.
  • Knowledge of the scientific and engineering principles pertaining to and capable in the operation of standard laboratory, analytical, and/or processing and manufacturing equipment.
  • A good understanding and application of relevant scientific theories, principles, and methods.
  • 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.
  • Understanding of Lean/Six Sigma/QbD principles is preferred.
  • Understanding of FDA/EU Regulatory Guidance Framework, Industry Best Practices and cGMPs is preferred
  • Experience designing and conducting studies based on statistical Design of Experiments principles is preferred
  • Knowledge and capability to support and facilitate most of the following tasks is preferred:
    • 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
  • Effective written and verbal communication skills.
  • 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 149902

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.
 


Nearest Major Market: Birmingham