Process Engineer

3 weeks ago

Marietta, Georgia, United States Avion & Acella Pharmaceuticals Full time
Job Description

Avion & Acella Pharmaceuticals is seeking a highly skilled Process/Project Engineer to join our team. As a Process/Project Engineer, you will be responsible for providing engineering expertise for installation, startup, and operation of new and existing processes in our Oral Solid Dose Pharmaceutical manufacturing environment.

Key Responsibilities:
  • Standardize existing manufacturing processes to increase robustness and compliance.
  • Develop and implement product manufacturing process improvements for existing processes.
  • Troubleshoot and resolve manufacturing process problems.
  • Develop process documentation and training material to support 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.
Requirements:
  • 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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