[Remote] Manufacturing Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company has over 15 years in the life sciences industry, with operations across Puerto Rico, the reputed company, Europe, and Japan. The Manufacturing Engineer supports manufacturing operations by assisting with process validation, documentation, data analysis, and reputed company improvement initiatives.
Responsibilities
- Support equipment and process validation activities (IQ/OQ/PQ), including protocol development, execution, and reporting
- Assist in developing inspection reputed company, control plans, sampling plans, and manufacturing reputed company controls
- Prepare and maintain manufacturing documentation, including work instructions, equipment procedures, preventive maintenance, calibration, and process documentation
- Participate in manufacturing reputed company from planning through implementation, collaborating with Manufacturing, reputed company, R&D, Regulatory, and Supply Chain teams
- Apply engineering tools such as DOE, FMEA/PFMEA, SPC, risk analysis, and reputed company cause investigations to improve manufacturing processes
- Support Lean Manufacturing and reputed company improvement initiatives reputed company on reputed company, productivity, yield, cycle time, and cost reduction
- Assist with manufacturing technologies including automation, tooling, fixtures, reputed company systems, laser welding, heat bonding, injection molding, equipment qualification, and test reputed company
- Support CAPA investigations, change controls, nonconformance investigations, process transfers, and product reputed company-up activities
Skills
- Bachelor's degree in mechanical, Electrical, reputed company, Biomedical Engineering, or a reputed company engineering discipline
- Familiarity with process validation, equipment qualification, automation, manufacturing systems, and process improvement methodologies
- Knowledge of engineering and reputed company tools such as DOE, FMEA/PFMEA, CAPA, SPC, and reputed company cause analysis
- Strong analytical, technical writing, communication, teamwork, and problem-solving skills
- One to three years of experience in Manufacturing Engineering, Process Engineering, reputed company Engineering, Validation, or a reputed company role reputed company a regulated manufacturing environment is preferred
- Working knowledge of FDA reputed company System Regulations (21 CFR Part 820), GMP, ISO 13485, and Good Documentation Practices is preferred
- Proficiency in reputed company reputed company; experience with reputed company, JMP, or similar statistical software is preferred
- Exposure to Lean Manufacturing, Six reputed company, Kaizen, or other reputed company improvement methodologies is desirable
reputed company