JT751 - ASSOCIATE PILOT PLANT

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.

In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities :

• Perform large-scale upstream cell culture and downstream purification manufacturing operations up to the 200L-500L scale spanning from vial thaw through freezing of formulated drug substance.
• Operate, setup, and troubleshoot bioprocessing equipment such as rocking and single-use bioreactors, single-use chromatography and filtration systems (TFF, VF, UFDF), and others as needed.
• Pack and qualify chromatography columns up to 40 cm in diameter.
• Perform testing of samples on various analytical instruments.
• Document work in electronic lab notebooks per GDP principles while following appropriate SOPs.
• Write, review & revise documentation ( SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc).
• Monitor and analyze process performance for atypical trends and improvement opportunities.
• Perform basic troubleshooting and collaborate with Management, Engineering, Automation and others as appropriate to resolve manufacturing events in a timely manner.
• Generate, analyze, and summarize process data to identify and mitigate challenges to future commercial processes, and support new technology development, new product introductions, and facility tech transfers.
• Participate in cross-functional teams and represent Pilot Plant as needed.
• Escalate appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Adherence to all regulatory requirements, written procedures, policies, and safety guidelines at all times.
• Identify, recommend, and implement improvements related to routine functions ( facilitate the drive towards continuous improvement in the plant ).
• Maintain an organized and clean workspace.
• Contributes to general housekeeping and 5S initiatives.

Qualifications :

Ability to interpret and apply GDP, FAIR, and ALCOA+ principles to everyday work.

Shift :