Job Title:
Biotech Associate – Upstream/Downstream Operations (Production Operator)
Location:
Dunboyne, Ireland
Shift Role
Job Purpose:
The Biotech Associate will support the manufacturing and quality operations of biologics products. The role involves performing hands-on activities in upstream and downstream processing, assisting with technology transfers, batch operations, and ensuring compliance with cGMP and safety standards. The associate will also participate in process documentation, environmental monitoring, and continuous improvement initiatives.
Key Responsibilities:
* Perform daily manufacturing activities in upstream (cell culture, inoculation, bioreactor operations) and downstream (purification, filtration, chromatography) processes.
* Ensure strict adherence to cGMP, SOPs, and safety protocols in all operations.
* Assist in batch record preparation, data entry, and documentation to support regulatory compliance.
* Support technology transfers, new product introductions, and process validation activities.
* Participate in environmental monitoring, cleanroom compliance, and equipment cleaning/maintenance.
* Collaborate with cross-functional teams (Quality, Manufacturing, Analytics) to troubleshoot and optimize processes.
* Contribute to continuous improvement initiatives to enhance process efficiency, yield, and compliance.
Qualifications & Experience:
* Bachelor's or Master's degree in Biotechnology, Bioprocessing, Biological Sciences, or related field.
* Hands-on experience in cGMP-regulated laboratory or manufacturing environments.
* Familiarity with upstream and downstream bioprocessing techniques, sterile handling, and cleanroom operations.
* Knowledge of process documentation, batch records, and regulatory compliance.
* Strong teamwork, communication, and problem-solving skills.
Skills:
* Upstream/Downstream Bioprocessing
* Sterile Technique & Aseptic Handling
* Process Documentation & Data Entry
* Environmental Monitoring & Cleanroom Compliance
* GMP & SOP Adherence
* Team Collaboration & Communication