Job Title: Aseptic Process Specialist (Media Fill & Smoke Study)
Eligibility:
Open to Puerto Rico residents who are U.S. citizens.
Work Model:
Hybrid work arrangement available for qualified candidates.
Job Description:
Our client, a leading global biotechnology company located in the east region of Puerto Rico, is seeking a Aseptic Process Specialist to support aseptic operations and validation activities in compliance with cGMP and regulatory standards. The selected candidate will play a key role in the planning, execution, and evaluation of Media Fill simulations, Smoke Studies, and Airflow Pattern assessments, ensuring that aseptic manufacturing practices meet the highest quality and compliance expectations.
Key Responsibilities:
- Lead and execute Media Fill qualification studies and Smoke Profile/Flow Pattern evaluations to verify aseptic process integrity.
- Ensure all aseptic activities are performed in strict compliance with regulatory and internal quality requirements.
- Collaborate with cross-functional teams in Manufacturing, Validation, and Quality to identify and mitigate potential contamination risks.
- Analyze data, prepare technical reports, and present findings to support regulatory inspections and audits.
- Provide technical guidance and training related to aseptic techniques and environmental monitoring practices.
- Participate in continuous improvement initiatives to enhance aseptic process performance and compliance.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Microbiology, or a related field.
- 5–8 years of hands-on experience in aseptic processing within an FDA-regulated or biotechnology environment.
- Proven expertise in Media Fills, Smoke Studies, Flow Pattern analysis, and aseptic technique assessments.
- Strong knowledge of cGMP, FDA, EMA, and global aseptic processing regulations.
- Excellent analytical, documentation, and communication skills.
- Bilingual (English and Spanish) preferred.
Invitation to Apply
Qualified professionals who meet the above criteria are encouraged to apply inside the job description link with an updated resume for immediate consideration. Join our client’s team and contribute to advancing innovative biotechnological solutions in a dynamic, world-class environment.