What are the responsibilities and job description for the BFS Changeover Specialist position at NEPHRON SC, LLC?
Description
Corporate Statement
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.
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Job Purpose:
The Changeover Specialist plays a crucial role in pharmaceutical manufacturing by ensuring efficient and accurate equipment transitions between production runs. This position is responsible for executing Clean-in-Place (CIP) and Sterilize-in-Place (SIP) procedures, managing end-of-lot processes, facilitating line start-ups, and performing level one maintenance to maintain seamless operations. The Changeover Specialist works closely with machine operators, technicians, and maintenance teams to ensure compliance with Current Good Manufacturing Practices (CGMP), safety regulations, and production standards.
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Essential Duties and Responsibilities:
Equipment Changeovers & Line Start-Up:
Ø Execute efficient and precise equipment changeovers to minimize downtime between production runs.
Ø Ensure that all changeover activities are performed in accordance with Standard Operating Procedures (SOPs) and Master Batch Records.
Ø Perform pre-production checks to verify correct machine setup and readiness before initiating a new production cycle.
Ø Collaborate with operators and technicians to troubleshoot and resolve setup issues.
CIP (Clean-in-Place) & SIP (Sterilize-in-Place):
Ø Perform CIP and SIP procedures to maintain equipment sterility
Ø Monitor and document cleaning cycles to ensure compliance with validated cleaning protocols.
Ø Assist in troubleshooting CIP/SIP deviations and implementing corrective actions.
Ø Ensure proper handling and disposal of cleaning agents and sterile solutions in accordance with environmental and safety regulations.
Level One Maintenance & Troubleshooting:
Ø Conduct minor maintenance tasks, including machine adjustments, lubrication, and component replacements.
Ø Reset alarms and troubleshoot basic mechanical and electrical issues to maintain production flow.
Ø Assist maintenance teams with preventive maintenance and escalation of complex technical issues.
Ø Document all maintenance activities in compliance with CGMP and regulatory requirements.
Quality & Compliance:
Ø Ensure all changeover, cleaning, and maintenance activities meet CGMP and FDA regulatory standards.
Ø Accurately complete documentation, including logbooks, changeover records, and maintenance reports.
Ø Support investigations related to deviations, non-conformances, and corrective actions.
Ø Participate in audits and regulatory inspections as required.
Ø Must maintain current training and certifications in compliance with company and regulatory requirements.
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 & Continuous Improvement:
Ø Work closely with cross-functional teams, including Production, Quality, and Maintenance, to optimize changeover efficiency.
Ø Identify opportunities for process improvements and contribute to lean manufacturing initiatives.
Ø Assist in training and mentoring operators on proper changeover, cleaning, and maintenance procedures.
Training & Development:
Ø Mentor and train junior changeover specialist, BFS technician or 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.
End-of-Lot Process Management:
Ø Oversee end-of-lot procedures, including documentation, equipment clearance, and line clearance verification.
Ø Perform required cleaning and preparation for the next production run.
Ø Ensure proper segregation and handling of in-process and finished product materials.
Supplemental Functions:
Ø Performs all other duties as assigned or apparent.
Job Specifications and Qualifications:
Knowledge:
Ø Familiarity with BFS technology and sterile manufacturing processes is a plus.
Ø Strong understanding of CGMP, FDA, and industry regulatory requirements.
Ø Hands-on experience with CIP, SIP, and changeover processes.
Ø Basic mechanical aptitude with the ability to perform level one maintenance.
Ø Proficient in reading and interpreting SOPs, batch records, and technical documents.
Ø Strong attention to detail, problem-solving skills, and ability to work in a fast-paced environment.
Ø Effective communication and teamwork skills.
Education / Experience:
Ø High school diploma or equivalent required; technical certifications in manufacturing, maintenance, or engineering preferred.
Ø Minimum of 2-5 years of experience in a pharmaceutical, food, or regulated manufacturing environment.
Licensing and Certification:
Ø Certification in Lean Manufacturing, Six Sigma, or similar process improvement methodologies.
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Working Conditions / Physical Requirements:
Ø Must be comfortable working in a cleanroom environment and wearing PPE (gowns, gloves, masks, etc.).
Ø Ability to lift up to 50 lbs., stand for extended periods, and work flexible shifts, including nights, weekends, or holidays as needed.
Ø Salary: Based on experience.
Ø Schedule: 12-hour shifts (0600-1830, 1800-0630)
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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.
