Aseptic Process Specialist (Media Fills)

Job Title: Aseptic Process Specialist (Media Fill)

Location: Puerto Rico (Open to Puerto Rico residents who are U.S. citizens)

Employment Type: Contract opportunity through ProQuality Network

Work Model: Hybrid arrangement available for qualified candidates

Job Description

We are seeking an experienced Aseptic Process Specialist to manage the planning, coordination, and execution oversight of Media Fill simulation processes and Smoke Studies for our client’s aseptic manufacturing operations. The selected professional will ensure that aseptic simulations and airflow studies are conducted in full alignment with current good manufacturing practices (cGMP), regulatory expectations, and internal quality standards.

This role requires strong technical knowledge of aseptic environments, airflow dynamics, and contamination control principles to support aseptic assurance and process robustness across cleanroom operations.

Key Responsibilities:

• Manage the overall Media Fill simulation process, including planning, scheduling, and coordination with Quality, Manufacturing, and Validation teams.
• Oversee Smoke Studies and Flow Pattern assessments, ensuring proper execution, documentation, and interpretation of results.
• Review and analyze smoke profile videos and airflow data to confirm compliance with aseptic processing requirements.
• Provide technical leadership and guidance during aseptic process simulations to ensure adherence to contamination control strategies.
• Support risk assessments, deviation investigations, and CAPA implementation related to aseptic operations.
• Maintain accurate and compliant documentation aligned with FDA, EMA, and global aseptic processing standards.
• Collaborate with cross-functional teams to enhance process design and strengthen aseptic behavior training initiatives.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Microbiology, or a related field.
• 5–8 years of experience in aseptic processing within an FDA-regulated or biotechnology environment.
• Proven expertise managing Media Fill simulations, Smoke Studies, and Flow Pattern analysis.
• Strong understanding of cGMP, FDA, EMA, and global aseptic processing regulations.
• Excellent organizational, analytical, and communication skills.
• Bilingual (English and Spanish) preferred.

Invitation to Apply

Qualified professionals are encouraged to apply through the job description link with an updated resume for immediate consideration.

Join our client’s team and contribute to advancing aseptic process excellence and sterility assurance in a world-class biopharmaceutical manufacturing environment.