BFS Machine Operator

2 weeks ago

Columbia, Missouri, United States NEPHRON SC, LLC Full time $60,000 - $90,000 per year

Job Purpose: 

The Machine operator Blow Fill Seal (BFS) plays a key role in pharmaceutical manufacturing by operating, maintaining, and monitoring BFS equipment to produce sterile pharmaceutical products. This role ensures compliance with Current Good Manufacturing Practices (CGMP), safety standards, and company procedures to achieve consistent production quality.

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Essential Duties and Responsibilities:

Equipment Operation:

Ø Set up and operate BFS downstream machines to manufacture pharmaceutical products in alignment with established Procedures, Forms, and Master Batch Records.

Ø Monitor equipment performance throughout production to ensure optimal efficiency.

Ø Perform minor machinery adjustments to maintain smooth operations.

Ø Reset alarms on LGV and downstream equipment as necessary.

Ø Transport goods or materials required for batch processing.

Quality and Documentation:

Ø Escalate product quality or equipment performance concerns to supervisors promptly.

Ø Maintain accurate and timely production records, including Batch Records, Logbook entries, Machine Setup Sheets, and Forms, in compliance with CGMP standards.

Ø Complete internal training on procedural updates within the required timelines.

Ø Follow all safety, environmental, and operational protocols without exception.

Ø Support deviation investigations and assist in implementing corrective actions.

Ø Complete all assigned training and certifications.

Ø Review MBRs and log book for accuracy and GMP standard.

Safety & Housekeeping:

Ø Promote and enforce safety policies, ensuring a secure work environment.

Ø Ensure cleanroom and production areas align with procedural standards and cleanliness.

Ø Ensure daily housekeeping is maintained by verifying logs and conducting facility or area walk throughs. 

Collaboration:

Ø Partner with cross-functional teams, including Quality, Maintenance, and Packaging, to support seamless production operations.

Ø Participate in training sessions to enhance technical knowledge and procedural skills.

Training & Development:

Ø Mentor and train junior machine operator and new team members on equipment operation, safety procedures, and best practices.

Ø Must maintain current training and certifications in compliance with company and regulatory requirements.

Supplemental Functions:

Ø Performs all other duties as assigned or apparent.

Job Specifications and Qualifications: 

Knowledge:

Ø Prior experience in pharmaceutical manufacturing or sterile production preferred.

Ø Familiarity with BFS technology is an advantage.

Ø Basic understanding of mechanical systems and machine operation.

Ø Proficient in reading and interpreting SOPs, batch records, and technical documents.

Ø Strong attention to detail and commitment to quality.

Ø Ability to follow instructions precisely and adapt to changing priorities.

Ø Effective communication and teamwork skills.

Education / Experience:

Ø High school diploma or equivalent; technical certifications preferred.

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