Blow-Fill-Seal Maintenance Technician
Entry o Mid-level Techs needed.
Job Summary:
This individual is tasked to ensure company operations comply with laws, regulations, standards, and internal procedures, including FDA, ISO 13485, ISO 14001, and occupational health standards. The role emphasizes Environmental, Health, and Safety (EHS) initiatives and continuous improvement, while supporting reasonable accommodations for individuals with disabilities.
Essential Job Functions:
- Operate BFS machines and equipment to produce sterile solutions.
- Start-up and maintain the purified water system.
- Compound solutions following standard operating procedures (SOPs).
- Ensure equipment operates properly and meets product standards.
- Adhere to Good Manufacturing Practices (GMP) and documentation standards.
- Perform physical tasks such as lifting (up to 100 lbs) and using tools.
- Perform additional duties as needed.
Minimum Requirements:
- Education: High school diploma or GED; higher education preferred.
- Experience: Background in mechanical systems (e.g., automotive repair, blow molding, filling operations).
Skills:
- Proficient in reading blueprints; electronics knowledge is a bonus.
- Experience in cGMP environments or similar fields preferred.
- Strong English reading, writing, and procedural compliance skills.
