Job Purpose:

The BFS Maintenance Technician 1 is an entry-level role focused on assisting with the operation and basic maintenance of Blow-Fill-Seal (BFS) equipment. This role supports senior technicians and line mechanics by performing routine preventive maintenance, documenting work activities, and helping resolve minor mechanical and electrical issues. The Technician 1 ensures operations meet CGMP and safety standards while gaining hands-on experience in sterile pharmaceutical manufacturing.

Essential Duties and Responsibilities:

Equipment Support & Basic Maintenance:

Ø Assist in the operation and routine maintenance of BFS production equipment.

Ø Perform basic troubleshooting under supervision (e.g., minor jams, adjustments).

Ø Support changeovers and machine setups.

Ø Help identify and report unusual machine behavior or defects.

Compliance & Documentation:

Ø Follow all CGMP and FDA guidelines in cleanroom and production areas.

Ø Complete maintenance logs and standard forms accurately and on time.

Ø Support SOP adherence and equipment checklists during each shift.

Training & Development:

Ø Participate in on-the-job training under guidance from BFS Maintenance Technician 2 or Supervisor.

Ø Learn technical fundamentals of BFS equipment, cleanroom and compliance procedures.

Ø Attend assigned training and demonstrate growing mechanical competence.

Safety & Cleanroom Expectations:

Ø Follow all safety rules and lockout/tagout procedures.

Ø Wear appropriate PPE and comply with gowning requirements including proper aseptic technique.

Ø Sanitize tool, equipment and area as necessary by procedures.

Job Specifications and Qualifications:

Knowledge:

Ø Basic understanding of mechanical or electrical systems.

Ø Willingness to learn BFS equipment and maintenance practices.

Ø Familiarity with tools, safety procedures, and production environments.

Education / Experience:

Ø High school diploma or GED required.

Ø 1-2 years of experience in a manufacturing, maintenance, or technical support role preferred.

Ø Prior BFS experience preferred; training provided.

Licensing and Certifications:

Ø Technical certification in maintenance, electrical, or mechanical systems preferred but not required.

Working Conditions / Physical Requirements:

Ø Ability to lift up to 50 - 70 lbs, bend, reach, and stand for extended periods.

Ø Must be able to work in a cleanroom setting with appropriate PPE.

Ø 12-hour rotating shifts (2-2-3 schedule); shift assignment may vary.

Ø Salary range: Based on experience.

Ø May be asked to participate in on-call rotation.