BFS Machine Operator

Nephron Pharmaceuticals; West Columbia (SC); On-site; USD 35,000 - 50,000; Full time

Job summary

A leading pharmaceutical company seeks a Machine Operator for Blow Fill Seal (BFS) manufacturing to ensure the production of sterile products. This role involves equipment operation, monitoring, and compliance with safety standards in a cleanroom environment, ideal for those with background in sterile production processes.

Qualifications

• Prior experience in pharmaceutical manufacturing or sterile production preferred.
• Basic understanding of mechanical systems and machine operation required.
• Familiarity with BFS technology is an advantage.

Responsibilities

• Set up and operate BFS downstream machines to manufacture products.
• Monitor equipment performance to ensure optimal efficiency.
• Maintain accurate production records in compliance with CGMP standards.

Skills

Attention to detail

Effective communication

Teamwork

Education

High school diploma or equivalent

Technical certifications (preferred)

Job description

Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on : Transformation , Execution and Trust .

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.

Essential Duties and Responsibilities :

Equipment Operation :

• Set up and operate BFS downstream machines to manufacture pharmaceutical products in alignment with established Procedures, Forms, and Master Batch Records.
• Monitor equipment performance throughout production to ensure optimal efficiency.
• Perform minor machinery adjustments to maintain smooth operations.
• Reset alarms on LGV and downstream equipment as necessary.
• Transport goods or materials required for batch processing.

Quality and Documentation :

• Escalate product quality or equipment performance concerns to supervisors promptly.
• Maintain accurate and timely production records, including Batch Records, Logbook entries, Machine Setup Sheets, and Forms, in compliance with CGMP standards.
• Complete internal training on procedural updates within the required timelines.
• Follow all safety, environmental, and operational protocols without exception.
• Support deviation investigations and assist in implementing corrective actions.
• Complete all assigned training and certifications.
• Review MBRs and log book for accuracy and GMP standard.

Safety & Housekeeping :

• Promote and enforce safety policies, ensuring a secure work environment.
• Ensure cleanroom and production areas align with procedural standards and cleanliness.
• Ensure daily housekeeping is maintained by verifying logs and conducting facility or area walk throughs.
• Partner with cross-functional teams, including Quality, Maintenance, and Packaging, to support seamless production operations.
• Participate in training sessions to enhance technical knowledge and procedural skills.

Training & Development :

• Mentor and train junior machine operator and new team members on equipment operation, safety procedures, and best practices.
• Must maintain current training and certifications in compliance with company and regulatory requirements.

Supplemental Functions :

• Performs all other duties as assigned or apparent.

Job Specifications and Qualifications :

Knowledge :

• Prior experience in pharmaceutical manufacturing or sterile production preferred.
• Familiarity with BFS technology is an advantage.
• Basic understanding of mechanical systems and machine operation.
• Proficient in reading and interpreting SOPs, batch records, and technical documents.
• Strong attention to detail and commitment to quality.
• Ability to follow instructions precisely and adapt to changing priorities.
• Effective communication and teamwork skills.

Education / Experience :

• High school diploma or equivalent; technical certifications preferred.

Licensing and Certification :

• N / A

Working Conditions / Physical Requirements :

• Ability to lift and carry heavy equipment (up to 50 lbs), stand for extended periods and work in a cleanroom environment.
• Comfortable wearing personal protective equipment (PPE), such as gloves, gowns, masks and goggles.
• Salary range : Based on experience.
• Hours of Work : 12-hr shift work (0600-1830, 1800-0630).

The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description.

Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law.

Nephron Pharmaceuticals is a drug free workplace.

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