Skip to Main Content
← Back to Jobs

Process Engineer

Denison Pharmaceuticals Providence, RI
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

This position requires in-depth knowledge and hands-on experience in Filling and Packaging Process Engineering involving semi-solids (creams, ointments, lotions, gels, etc.), liquids, and suspensions products.

Process Engineer will be able to perform duties related to pilot/scale-up and commercial batch filling and Packaging while collaborating with other internal departments/divisions such as R&D Formulation and Analytical, Packaging Operations, Quality Operations, and Project Management.


  • Responsible for drafting/reviewing/approving Packaging Work Orders, Packaging Validation Protocols, OOSs/deviations, change controls, SOPs, etc..
  • Oversee filling and packaging activities during Engineering Batches Line Trials and Validations.
  • Advise/guide fill/pack personnel as and when needed basis.
  • Troubleshoot fill/pack issues, identifying the root cause and owning resolution and corrective actions.
  • Represent technical operation division in daily operation meetings and during clients onsite visit.
  • Collaborate with internal divisions, clients, and vendors for technical operations related activities.
  • Proactively research/review/implement new filling and packaging process engineering techniques/instrumentations.
  • Assist with the review and approval of new packaging components.
  • Troubleshoot issues that arise and solve problems.

Requirements

  • Degree in Engineering/ Industrial Pharmacy with a minimum of 5 years experience in filling and Packaging of pilot/commercial batches.
  • Prefer familiarity with liquids, suspensions, solutions, and semi-solid pharmaceutical dosage forms, cGMPs, and USP.
  • Understanding of regulatory requirements related to pharmaceutical product development/manufacturing.
  • Excellent scientific writing skills.
  • Ability to multi-task various activities.
  • Ability to collaborate with R&D Formulation/Analytical, Packaging Operations, Quality Operations to enhance cross-functional transparency and execution success.
  • Excellent time management and the ability to work under pressure.
  • Ability to discuss scientific strategies/results and interact with the clients internal departments
  • Working experience in an FDA regulated environment using GMP/cGMP processes and documentation requirements.
  • Advanced level knowledge of Microsoft Word, Excel and PowerPoint.
  • Highly motivated individual and willing to learn and grow professionally.

Denison Pharmaceuticals

Address

Providence, RI
USA