Process Development Engineer (1st Shift)

Summary of primary Duties and Responsibilities:

  1. Basic Office Setting – Exposure to Computer Monitor
  2. Physical Requirements – Not Applicable
  3. Occasional Travel
  4. Business Dress plus ability to Gown for Manufacturing
  5. I will abide by all cGMP, FDA and DEA regulatory standards
  6. Under supervision of senior associate, plan and execute process studies for feasibility, development/characterization (Design Of Experiments), and qualification of new products.
  7. Recommend changes to process conditions for product quality, throughput, and yield.
  8. Write master batch records, protocols, Standard Operating Procedures, process development reports, etc.
  9. Analyze data and assist in solving technical problems.
  10. Support Validation group with Failure Mode and Effects Analysis (FMEA) and Risk Assessments as needed.
  11. Maintain accurate and complete records of development activities in accordance with cGMP guidelines.
  12. Interface with project teams, vendors, and clients in all activities from development to validation scale production.
  13. Provide technical and/or scientific guidance to internal teams when appropriate.
  14. Support the hand-off from process development and scale up to validation and commercial manufacturing.
  15. Other duties as assigned.

Qualifications/Requirements:

  • Minimum of BS degree chemical or mechanical engineering or related field.
  • Highly motivated individual who can work both independently and as part of a cross-functional team.
  • Strong interpersonal, problem-solving and analytical skills.
  • Strong technical writing and oral communication skills. Must be able to effectively communicate results or issues, verbally and in writing.
  • Ability to work within a GMP environment with hazardous materials.
  • Strong computer skills (Microsoft Office, Word, Excel)
  • Participate in occasional domestic and international travel as required

Preferred Skills/Abilities:

  • 0-3 years hands-on experience in manufacturing process development and scale-up, preferably with transdermal and oral dissolvable thin film products, OR, experience with pressure sensitive adhesive mixing and coating.
  • Knowledgeable and experienced with cGMP and the regulatory requirements for pharmaceuticals preferred.
  • Demonstrated experience drafting Batch Records, SOPs, master plans and additional protocols
  • Proven scientific and technical ability to design and execute experimental studies as well as statistically analyze data, author and review protocols and reports.

Job Posting Eligibility Requirements:

  1. You must be in your present position for a minimum of six months.
  2. You must meet the qualifications/requirements listed above.
  3. Your most recent evaluation must reflect your job performance as satisfactory or better.

Job Posting Application Procedure

  1. Complete a job posting application form, available in the Human Relations Department.
  2. Return the completed form to Human Relations by the closing date noted above.
  3. You will be contacted within a reasonable timeframe after the close of the posting.

Department: Tech Transfer
Reporting to: Director – Research & Development