TOLMAR Inc.

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Process Development Engineer II

at TOLMAR Inc.

Posted: 6/23/2019
Job Status: Full Time
Job Reference #: a5c46a30-ed2f-4e7d-8e0d-ea24ef885069

Job Description

Purpose and Scope

Assists with the design and implementation of manufacturing processes, instrumentation and equipment from the laboratory through pilot plant and manufacturing scale-up.  Provides support in developing and recommending new process technologies to achieve improved product quality and cost effectiveness.

Essential Duties & Responsibilities

  • Work with formulation team to develop manufacturing processes for new products.
  • Help make process design decisions, provide input and recommendations.
  • Perform scale-up activities to increase batch size from laboratory to clinical scale, and from clinical to commercial scale.
  • Write protocols, reports, SOPs, user requirement specifications, laboratory notebook studies, and other controlled documents.
  • Help execute process validation protocols and write validation reports.
  • Interface with equipment vendors to specify equipment, request quotes and order equipment.
  • Design and execute process development studies and experiments to understand and improve processes.
  • Develop cleaning processes and perform cleaning validation.
  • Coordinate activities for production of clinical batches, “hands on” execution of development and clinical batches.
  • Train manufacturing personnel in technical manufacturing processes.
  • Experience of successful interfacing with Formulation Development, Regulatory, Facilities, Manufacturing, Validation, Quality and various departments for product development.
  • 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 CP 030-0202 Chemical Spill Response.
  • Perform other related duties as assigned.

Knowledge, Skills & Abilities 

  • Knowledge of pharmaceutical process development, scale-up and validation.
  • Understanding of cGMP requirements to produce the documentation necessary for manufacturing development batches within a GMP environment.
  • Mechanical aptitude and ability to operate equipment.
  • Knowledge of pharmaceutical manufacturing operations and specialty injectable products is desirable, but not required.
  • Effective technical writing skills (batch records, protocols, etc.)
  • Must be able to work in a fast-paced, changing work environment, possess good time management skills, and exhibit personal responsibility.
  • Effective interpersonal communication skills.
  • Ability to analyze complex problems and implement creative solutions.
  • Ability to learn new technology/new products quickly.
  • Ability to work independently, as well as cooperatively on a team.
  • Ability to manage multiple projects and prioritize/reprioritize work.
  • Positive attitude and willingness to perform labor-intensive work when necessary.

 Core Values

  • The Process Development Engineer II 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

  • Bachelor of Science in Chemical Engineering or other Engineering discipline. Degrees in other scientific discipline may be considered.
  • Three or more years’ experience in product and/or process development in the Pharmaceutical/Biotech industry.

 Working Conditions

  • Working conditions are in an office, laboratory and pharmaceutical 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.