Process Project Engineer

2 days ago

Marietta, United States Avion & Acella Pharmaceuticals Full time

Osmotica Pharmaceuticals

Job Description

Process/Project Engineer

Responsibilities:

The responsibilities will include process engineering and project engineering responsibilities in an Oral Solid Dose Pharmaceutical manufacturing environment. The process/project engineer will provide engineering expertise for installation, startup and operation and optimization of new and existing processes. This role will help us ensure that we have robust, compliant, and efficient manufacturing processes.

  • Standardize our existing manufacturing processes (both equipment and steps) to increase robustness and compliance.
  • Develop and implement product manufacturing process improvements for existing processes.
  • Troubleshoot and resolve manufacturing process problems—determining root cause and corrective actions.
  • Develop process documentation and training material to support the standardized processes and new product launches.
  • Provide requested documentation to support compliance requirements for existing products and for new product regulatory filings
  • Provide process engineering recommendations to R&D during the development phases to ensure development of new products that can be manufactured robustly as the current level of existing technology.
  • Provide process engineering recommendations to R&D and Manufacturing on compliance and product quality during the development phase, through to ongoing commercial operations.
  • Transition new products into production working as a member or leader of the technology transfer team to ensure that the new product meets production, quality, and compliance requirements
  • Serve as Subject Matter Expert and Trainer for key manufacturing processes
  • Provides manufacturing process leadership through process improvement and optimization
  • Initiate and conducts validation of production processes and test equipment
  • Identify quality issues and manage resolutions
  • Resolve non-conforming material issues and coordinate corrective measures
  • Review and recommend equipment for capital expenditures, generating appropriate CAPEX requests
  • Developing Engineering Preventative Maintenance Forms, Engineering Standards, Training Materials, Standard
  • Operating Procedures, and Batch Records relating to new technology introductions.
  • Capable of reading, using, and creating engineering drawings using AutoCAD.
  • Leads new project and capital project work and installation/implementation/qualification of new equipment,
  • facilities and processes.
  • Responsible for creating and delivering training materials to mechanics, production technicians and users for new technology.
  • Responsible for working with the Original Equipment Manufacturers (OEM) to acquire expert knowledge for transfer internally and personal growth.
  • Leading the implementation of new equipment, policies and/or procedures.
  • Works on highly complex problems where analysis requires evaluation of multiple factors.
  • Exercises independent judgment in developing methods, techniques and evaluation criteria.
  • Demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Coordinates activities with Manufacturing and Pharmaceuticals technology teams to ensure proper prioritization.
  • Designs and interprets technical studies and data in order to resolve technical issues encountered during each
  • project. Helps to define technical objectives and to convey them to the other members of the project team.
  • Determines approaches to be utilized for assigned projects, then plans and executes work independently with minimal supervision.

Core Competencies:

  • Strong interpersonal and leadership skills necessary to communicate clearly and effectively and coordinate activities with all levels of personnel from various disciplines including Manufacturing Operations, Quality Assurance, Analytical Sciences, Pharmaceutical Sciences, Metrology, Facilities, and Regulatory Affairs.
  • Must have practical working knowledge of engineering disciplines (e.g. fluid flow, thermodynamics, heat transfer and engineering materials.)
  • Understanding of pharmaceutical manufacturing processes, packaging and equipment
  • Adept at use of personal computers and various software programs (e.g., Word, Excel, Project), for data acquisition, problem analysis, word processing and project management
  • Working knowledge of cGMP’s
  • Can operate with little supervision; must be self-motivated and largely self-directed


Minimum Qualifications

  • Bachelor’s Degree in an Engineering Discipline(required), chemical, mechanical preferred
  • 3+ years of demonstrated increasing responsibility in a pharmaceutical cGMP environment or the equivalent
  • Ability to lead hourly associates as required
  • Prior experience in an FDA regulated industry
  • Ability to travel up to 10% of time
  • Experience in the principles of equipment design/operations and validation of at least 4 of the following: Facilities (including design, material and personal flow analysis, HVAC/HEPA), utilities (including WFI & purified water, clean steam, compressed process air), Clean-In- Place system, Packaging Equipment, solid dosage equipment, process and cleaning validation.

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