Mechanical Technician

Job Summary : 2nd & 3rd Shift

The Mechanical Technician is responsible for overseeing the operation and maintenance of mechanical systems, including BFS machines and purified water systems, in a cGMP-compliant environment.

This position ensures compliance with all applicable regulations (FDA, ISO 13485, ISO 14001, etc.) and promotes continuous improvement in Environmental, Health, and Safety initiatives.

The role requires hands-on involvement in daily production activities, adherence to Good Manufacturing Practices, and leadership in maintaining operational efficiency.

Essential Job Functions :

• Set up, operate, and maintain BFS machines and support equipment to produce sterile bottled solutions.
• Oversee the operation of the purified water system, ensuring consistent, high-quality production.
• Compound solutions according to Standard Operating Procedures (SOPs) and prescribed formulations.
• Monitor machinery to ensure smooth operations and adherence to product quality standards.
• Follow written operating procedures and ensure team compliance with Good Manufacturing Practices (GMP) and Workplace Contamination Rules.
• Document operational results following Good Documentation Practices (GDP).
• Engage the team in continuous Environmental, Health, and Safety (EHS) improvements.
• Recurring physical demands include standing, walking, crouching, using tools, frequently lifting up to 30 lbs., occasionally lifting up to 50 lbs.

and rarely lifting up to 100 lbs.

Perform other duties as assigned by management.

Minimum Requirements :

• High school diploma or GED (higher education preferred).
• Proven experience with mechanical systems such as automotive repair, filling operations, or blow molding equipment.
• Familiarity with cGMP environments and filling operations is a plus.
• Ability to read and interpret blueprints; basic electronics knowledge is advantageous.
• Proficiency in reading and writing English, with the ability to follow written procedures and document results accurately.

Skills & Competencies :

• Strong mechanical aptitude with hands-on experience in machine operation and maintenance.
• Leadership skills with the ability to manage teams and ensure compliance with safety and quality standards.
• Attention to detail in ensuring machinery performance and adherence to product standards.
• Problem-solving skills to troubleshoot mechanical issues and suggest improvements.
• Ability to prioritize tasks and work effectively under pressure in a fast-paced production environment.
4 days ago