Process Development Engineer I - Temporary
Tolmar Inc.
 Windsor, CO

Requisition Number: PROCE03301

Purpose and Scope

Assists with the design and implementation of aseptic manufacturing processes, instrumentation and equipment from the laboratory through pilot plant and commercial manufacturing scale-up.

Essential Duties & Responsibilities

  • Assist other Process Development Engineers as needed to refine batch records, implementing changes when necessary to address manufacturing considerations including processing, manufacturability and scale-up.
  • Understand and improve process and equipment by working with formulation scientists, other engineers, and manufacturing personnel.
  • Assist with lab studies and scale up evaluations.
  • Help identify new equipment and components and solicit prices and quotes from vendors.
  • Update procedures and other controlled documents.
  • Help execute development batches, cleaning processes, and oversee execution of validation protocols.
  • Assist and train manufacturing personnel in technical manufacturing processes.
  • Help write numerous documents, protocols, specifications, reports, procedures, equipment qualification protocols, etc.
  • Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
  • Perform other related duties as assigned.

Knowledge, Skills & Abilities

  • Knowledge of FDA guidelines and cGMP Procedures.
  • Knowledge of aseptic processing
  • Understanding of cGMP requirements to produce the documentation necessary for manufacturing development batches within a GMP environment.
  • Knowledge of pharmaceutical process development, scale-up and validation.
  • Knowledge of chemistry, engineering principles, and pharmaceutical industry.
  • Familiarity with computer-aided design and other computer software (Word, Excel, Visio, for example).
  • Good documentation practice and technical writing ability.
  • Effective written and oral communication skills.
  • Ability to analyze complex development problems, propose and implement creative solutions.
  • Ability to work independently with minimal supervision as well as cooperatively on a team.
  • Must be able to work in a fast-paced, changing work environment, possess good time management skills and exhibit personal responsibility.

Core Values

  • The Process Development Engineer I is expected to operate within the framework of Tolmar’s Core Values:
    • Consistently operate with the highest standards of ethics and compliance.
    • Take ownership of your actions, success and setbacks.
    • Respect each other and understand that honest collaboration is at the heart of our company success.
    • Go the extra mile to make things happen.
    • Be committed to all we do and the patients we serve.
    • Embrace change with enthusiasm.
    • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

  • B.S. in an engineering discipline, chemical or mechanical engineering preferred. Degrees in other scientific discipline may be considered.
  • One or more years’ experience in an engineering environment within the Pharmaceutical/Biotech industry.

Working Conditions

  • Working conditions are in an office, laboratory and manufacturing environment.
  • Work may require occasional weekend and/or evening work.
  • Work may require lifting objects up to 25 lbs. and use of a respirator.

Compensation and Benefits

  • Pay Rate: $20-$25 per hour
  • Benefits information: https://www.tolmar.com/careers/employee-benefits
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