Process Engineer
4 days ago
Avion & Acella Pharmaceuticals is seeking a highly skilled Process Engineer to join our team. As a Process 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, determining root cause and corrective actions.
- 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.
- Provide manufacturing process leadership through process improvement and optimization.
- Initiate and conduct 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.
- Develop 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.
- Lead 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.
- 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, such as 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, such as 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.
- 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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Process Engineer
1 week ago
Marietta, Georgia, United States Avion & Acella Pharmaceuticals Full timeProcess Project EngineerAvion & Acella Pharmaceuticals is seeking a highly skilled Process Project Engineer to join our team. As a key member of our engineering team, 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...
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Marietta, Georgia, United States Avion & Acella Pharmaceuticals Full timeJob DescriptionAvion & 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...
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