JT751 - ASSOCIATE PILOT PLANT chez Quality Consulting Group

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: 

• Bachelor’s degree in Chemical Engineering (strongly preferred), Physics, Bioengineering, rather than just Chemistry, Biology.
• 1–5 years of relevant experience (academic, co-op, internship, or industry). 
• Knowledge of basic scientific/physical concepts such as pH, pressure, flowrate, mass, volume, density, geometry; ability to formulate and manipulate basic algebraic equations; ability to calculate basic quantities such as area, volume, density, flowrates, averages, percentages, dilutions).
• Effective Communication (clear, succinct, complete – both verbally & written)
• Digital Proficiency (ability to use basic computer programs such as Microsoft Word, Excel, PowerPoint, Outlook, Google Chrome, Windows File Explorer).
• Ability to interpret and apply GDP, FAIR, and ALCOA+ principles to everyday work.
• Ability to regularly lift up to 35 lbs, push and pull objects that require up to 50 lbs of force, and work on your feet for long durations.
• Ability to perform physical movements to perform daily tasks on the production floor such as bending, reaching above the head, climbing, kneeling, squatting, stooping, walking up or down stairs, and standing on portable stairs or ladders up to 6 feet off the ground.
• Ability to work some off-hours and weekends due to the nature of the work.
• Shift: 1st shift starting approx. 8:00 a.m. – 5:00 p.m. (Mon – Fri)
  • Due to cell culture & process schedules, there will be some weekend and evening work