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Sr. Engineer - Development

Date: Sep 14, 2021

Location: Birmingham, AL, US

Company: Evonik Industries AG

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VACANCY REFERENCE NUMBER 149897
 

Sr. Engineer - Development

 

Location: United States : Birmingham, AL

Function: Engineering

Career Level: Experienced professionals (2-5 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 the development of manufacturing processes for complex parenteral formulations through process design, equipment specification and procurement, and equipment and process qualification. This position provides oversight and technical leadership in developing and optimizing cGMP manufacturing operations for complex parenteral formulations, including providing engineering guidance for the safe handling of high potent active pharmaceutical ingredients, and is responsible for the preparation, review, and approval of process and equipment documentation (e.g. PFDs, URSs, EAFs, ETOPs, IQOQs, SOPs, MBPRs, etc.).

 

The position identifies and implements new technologies, processes, and/or instrumentation in order to grow the departmental capabilities. Furthermore, the position supports internal innovation and continuous improvement projects and knowledge management in order to increase scope and complexity of work conducted. This individual is responsible for the engineering aspects of product and process development as well as process trouble-shooting and optimization using a methodological approach (e.g. risk assessment, root cause analysis, Quality by Design, Design of Experiments, Design for Six Sigma, Lean Six Sigma, etc.). 

 

This position provides guidance and mentorship to technical leads of internal and/or customer projects or sub-projects. In addition, this position is responsible for the supervision and development of other engineers and co-operative education students/interns.
 

 

RESPONSIBILITIES

  • Project Execution, Support, and Oversight
    • Design, conduct, and evaluate results from experiments, internal and/or customer projects studies, and research programs in order to meet project goals and objectives; project activities may include process development and scaleup, equipment specification, document support, validation protocol review, and cGMP manufacturing support
    • Design, organize and lead development batches in support of pharmaceutical formulation research and development, engineering design, scale-up, and cGMP manufacturing operations
    • Oversee the development of technical plans and schedules and organize the execution of activities to achieve project objectives with respect to timelines and budget for multiple internal and/or customer projects
    • Ensure the proper documentation, review, and analysis of experimental activities, observations, data, and results
    • Identify areas of technical development based on current and future industry trends and initiate appropriate action in consultation with management
    • Review project proposals for appropriate technical scope and propose timelines and budgets for project proposals based on technical scope
    • Interact and communicate effectively with project teams, consultants, management, and clients
  • Continuous Improvement
    • Identify continuous improvement opportunities in documentation, quality, safety and daily operations and execute tasks and/or projects on gap closure or improvements; takes corrective action independently
    • Recommends and implements improvements in intra-departmental workflows, as required e.g. scale-up approach, development framework, transfer to manufacturing, etc.
    • Ensure further development and incorporation of cGMP, regulatory, and ISO knowledge in department in order to improve operations
  • Personnel Development
    • Mentor direct reports and provide feedback through the performance management program
    • Provide development opportunities to direct reports in alignment with career development pathways
    • Train direct reports and others in alignment with department objectives and goals
    • Support project teams in the development of project schedules and resource plans to execute complex parenteral formulation development projects with respect to timelines and budgets
    • Provide technical guidance to project teams through the application of formulation development stage-gates and phase-appropriate development, qualification, and validation activities
  • Other Responsibilities
    • Follow and ensure adherence to 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 QRA/HIRA/HAZIDs and proper process safety design, through PSSR review and approval
    • Follow and ensure adherence to cGMP regulations and procedures; generate and maintain thorough and accurate documentation in support of cGMP regulated activities
    • Review and approve quality change controls and deviations through the quality management system, i.e. Trackwise
    • Support management control system e.g. contribute to department meetings and contribute to effective communication of site, business line, and corporate topics
    • Review and approve of Standard Operating Procedures (SOPs), specifications, cGMP procedures, and training materials through the document management system, i.e. Regulus
    • Maintain and increase current scientific and engineering knowledge through review of current scientific and engineering literature and thereby develop appropriate ways, methods and tools for continuous improvement.
    • Contribute to the development of novel and proprietary technologies, methods, and Intellectual Property, as appropriate or in collaboration with the Research & Development unit (RDI).
 

REQUIREMENTS

  • 5+ years of directly related experience in process development in the pharmaceutical industry is required, experience in aseptic pharmaceutical manufacturing or development is a plus.
  • 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
  • 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 thorough understanding and application of relevant scientific and engineering 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 and engineering procedures and techniques.
  • A demonstrated ability to conduct assigned tasks independently with minimal oversight from management and ability work on multiple activities in parallel.
  • 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
  • Experience contributing to department and site continuous improvement initiatives regarding policies, procedures, workflows, process standardization, etc.
  • Knowledge of cGMPs, phase appropriate regulatory requirements, and the ability to appropriately scope complex parenteral formulation development projects with respect to technical scope, time, and budget.
  • General knowledge of several fields across the pharmaceutical product development process, multiple drug delivery technologies, or multiple analytical technologies.
  • Experience designing and conducting studies based on statistical Design of Experiments principles.
  • Knowledge and capability to 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.
  • Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or exposure to hazardous chemicals or high potent materials that could potentially affect the health of the employee.
  • Proficient in the use of word processing, spreadsheet and presentation software programs as well as project management software programs.
  • Excellent written and verbal communication skills
  • Excellent organizational and time-management skills.
  • Capable of independently managing research or development tasks of appropriate scope and complexity to achieve goals and objectives with consideration to budget and time schedules.
  • Experience leading and executing complex parenteral formulation development projects of varying scope.
  • Ability to identify training gaps, develop suitable training materials, and administer training to personnel.
  • Experience coaching performance and developing personnel.
  • 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 149897

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