Process Engineer

Company Info
Ethical Search Professionals
IL, United States

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Company Profile


Process Engineer


Milwaukee, WI 



Job ID:


Job Description:

The right individual will support tech transfers and scale-ups of API processes from Research and Development into cGMP manufacturing.  The Process Engineer is responsible for assessing process fit for new projects, troubleshooting unexpected manufacturing events, preparing, conducting and evaluating process validation activities, and providing on-going support of commercial manufacturing.  The Process Engineer I works closely with Research and Development, Manufacturing, QA, Regulatory, EHS, and Engineering to ensure first time right process scale-ups, tech transfer, and robust production of cGMP API materials.  The position requires superior leadership behaviors of the company's core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.


Essential Functions

  • Processes Fit assessment, Mass Balance, Energy Balance and Equipment Suitability assessments.
  • Partners with Research and Development to ensure process manufacturability during design.
  • Assists in Designing Experiments needed to establish Proven Acceptable Ranges for critical and key process parameters.
  • Understands relationships between Process Yield and Product Quality to achieve Process Optimization.
  • Writes protocols and reports needed to support Process Validation, process changes and equipment modifications.
  • Supports the creation and maintenance of cGMP production records.
  • Provides training to manufacturing staff on manufacturing procedures.
  • Troubleshoots unexpected events during cGMP manufacturing, assists in investigating and documenting process deviations and CAPAs.
  • Provides plant support.
  • Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
  • Complies with all company and site policies and procedures.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.


Key competencies

  • Maintains a safe, clean and organized work environment free of safety hazards.
  • Ability to work with people at all levels of the organization.
  • Ability to perform complex math functions, compute ratios, rates and percentages.
  • Ability to draw and interpret graphs and charts.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Ability to write reports, business correspondence and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers and clients.
  • Basic knowledge of computers and Microsoft Office software products.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
  • Duties, responsibilities and activities may change at any time with or without notice. 


Education and Experience

  • Requires a Bachelor’s degree in Engineering; Chemical Engineering strongly preferred.
  • Previous work experience in a regulated environment a plus.
EMPLOYMENT ELIGIBILITY: You must be legally authorized to work in the USA without the need for sponsorship, now or in the future