Manufacturing Engineer
3 weeks ago
At Global Pharma Tek, we are seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our manufacturing team, you will work closely with Design and Controls Engineers to assemble and debug equipment. Your responsibilities will include supporting Manufacturing and Quality Engineers in process validations of new and existing equipment, understanding and executing SOPs and Work Instructions, and developing and writing SOPs and Work Instructions. Additionally, you will support the development and maintenance of videos to supplement work instructions and support the development and modification of Preventive Maintenance routines. You will also use industrial CT scanning equipment for validation and digital metrology.
Qualification:
- Bachelor's degree in engineering or science required.
- Minimum 3 years full-time experience.
- Demonstrated knowledge of Six Sigma methodology, SPC techniques, and MINITAB data analysis.
- Three (3) years of practical medical device manufacturing experience is preferred.
- Working knowledge of FDA, cGMP, and ISO Standards/regulations.
- Good working knowledge of process validation, including protocol development.
- Ability to assess project risks and recommend contingency plans and strategies to mitigate quality risks.
- Strong process validation knowledge and background.
- Test method development and documentation.
- Experience with ASTM methods.
- Strong problem-solving skills and ability to make firm decisions.
- Organization and analytical skills.
- Knowledge of lab equipment, instruments, and calibration procedure.
- Ability to work in a cross-functional team setting.
- Detailed-oriented, high-energy, self-starter, who exercises sound judgment and delivers against company business goals and objectives.
- Excellent communication and presentation skills, both orally and written.
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