Manufacturing EngineerScope:
The primary job responsibilities for the Manufacturing Engineer are to develop and define processes and equipment types as well as specifications to achieve intended product design using glass fiber and polymer production. Engineer will take technical ownership for the cGMP production of the technology platform with support from the Research & Development team as well as Business Development team.
Minimum Qualifications
Education:
• Minimum of BS degree in Mechanical, Biochemical or Chemical Engineering or similar engineering field.
Experience:
• Must have 5-10 years’ experience in pharmaceutical or medical device engineering
• Demonstrated experience working with polymers and/or glass fiber and associated composites in a pilot plant or production environment.
• Experience with PLC based process automation.
• Good planning, organizational, decision-making, communication, and teamwork skills with a particular emphasis on process transfer, scale-up, and optimization.
• Ability to work with technical and non-technical personnel
• cGMP experience in the Medical Device or Pharmaceutical industry is highly preferred.
• Six Sigma experience
Responsibilities:
- Serve as the primary plant operations technical resource for the production areas. Spend significant time in a clean room environment, learning equipment operation and cross-training on all production operations for the Tucker site in order to serve as a back-up to the Engineer fulfilling a similar set of responsibilities in other production areas.
- Develop and define processes as well as equipment types, sizes and specifications to achieve intended product characteristics and quality. Transfer defined processes from the lab or pilot scale to plant scale equipment and then optimize, troubleshoot, improve and provide training to operators.
- Serve as the primary interface between the Tucker plant operations organization and the FiberLive technical and business development team. Responsible for the scale-up of new or revised processes, equipment qualification, process validation, cleaning validations, process mapping and efficiency, raw and in-process materials management and characterization, assist as required in the identification and qualification of outsourced raw materials suppliers, and in the creation, execution and review of production related documentation.
- Responsible for the generation and training of the production team regarding equipment/process SOPs and process batch records. Investigation of product quality deficiencies, proposal and implementation of process improvements, CAPAS, and investigating safety and operational issues with equipment and processes in assigned areas.
- Support production area efforts relative to equipment and system reliability by participating in process control, qualification and validation, equipment failure risk assessments and subsequent planning for preventative and predictive maintenance, spare parts, and calibration.
- Provide engineering and problem-solving support for process control, mechanical and utility systems for assigned area and to other areas as necessary. Work with external contractors and service providers as applicable.
- Provide project team support as a plant operations representative to capital investment projects as assigned.
- Reports to Plant Director; may be called upon to learn other polymer chemistry production operations conducted at plant and assist with a variety of site-wide issues or initiatives and/or assigned cross-functional task teams.
Pay:$90,000-$100,000/yr DOE + 10% bonus opporunity & benefits package
Travel:Moderate
