Manufacturing Support Specialist II

Summary

The Manufacturing Support Specialist II plays a crucial role in supporting manufacturing operations, with a focus on media and kit preparation, GMP cleaning, and ensuring compliance with cGMP guidelines. This position involves more advanced responsibilities, including the maintenance of GMP areas, cleaning of equipment, and supporting the manufacturing cell processing team. The specialist will also participate in the preparation of in-house solutions, assist with documentation updates, and ensure that all procedures adhere to GMP standards. As a more senior role, the Manufacturing Support Specialist II will take on additional leadership tasks, such as revising approved documents and supporting training activities within the team.

Responsibilities

Aseptic Cleaning & Maintenance:

• Participate in aseptic processing of in-house solutions according to cGMPs, focusing on routine aseptic processing and ensuring compliance with cGMP guidelines.
• Prepare cleaning solutions for sanitizing cleanrooms following approved procedures, ensuring that cleanroom areas, production zones, and laboratory environments are sterile.
• Perform thorough cleaning and sanitization of GMP cleanrooms, production areas, and laboratory environments using approved cleaning agents and disinfectants, following SOPs and aseptic techniques.
• Maintain cleanliness in GMP suites, gowning rooms, biosafety cabinets, and other critical areas, ensuring the environment is sterile and minimizing contamination risks.
• Execute cleaning and maintenance procedures for manufacturing equipment, ensuring compliance with current Good Manufacturing Practices (cGMP).
• Support the maintenance of the cleanroom environment to ensure it remains below alert level limits and complies with cleanliness standards.

Documentation & Compliance:

• Complete and maintain GMP documentation, including batch records, logbooks, and forms, in compliance with Good Documentation Practices (GDP).
• Revise and update approved documents, such as SOPs and batch records, to ensure accuracy and regulatory compliance.
• Accurately complete and maintain cleaning logs and other required documentation, adhering to GMP, FDA, and other regulatory standards.
• Participate in internal and external audits, ensuring the organization’s practices comply with GMP regulations.
• Prepare biopsy and product shippers, ensuring proper documentation and compliance with Electronic Batch Records (EBR).

Material & Equipment Management:

• Manage the inventory of cleaning materials, ensuring adequate stock levels and proper storage to avoid contamination risks.
• Execute routine transactions in the ERP system, including material requisitions and production tracking.
• Participate in material kit preparation and ensure all products are documented according to electronic batch records (EBR).

Safety & Training:

• Follow established safety protocols to ensure a safe working environment and prevent accidents.
• Support ongoing training efforts and assist in the development and improvement of cleaning procedures and protocols.
• Report deviations, non-conformances, and safety hazards immediately to the supervisor.

Collaboration & Process Improvement:

• Work closely with manufacturing, quality assurance, and other teams to ensure a coordinated approach to cleanliness and compliance.
• Participate in the development and improvement of cleaning procedures and protocols.
• Assist in data gathering efforts, troubleshooting, and compiling data as directed to support continuous improvement.
• Participate in cross-functional teams to enhance operational efficiency and support other duties as required to ensure effective manufacturing operations.

Qualifications

• AS/BS in Biotechnology, Biology, Chemistry, or related field preferred; relevant experience may substitute for formal education. Minimum 2 years of relevant experience in biotechnology manufacturing or a related field.
• Previous experience in a GMP environment, with knowledge of aseptic cleaning procedures and regulatory requirements, is highly preferred.
• Strong ability to follow production schedules and SOPs, exercising judgment within defined procedures.
• Proficiency in aseptic gowning, independent and team-based work, and strong organizational skills.
• Excellent documentation practices, with the ability to complete batch records, logbooks, and forms in compliance with GDP

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.