Quality Engineer I, Biologics Analytical Services

Quality Engineer I, Biologics Analytical Services

Position Summary

• Shift: Monday – Friday 8am-4:30pm
• 100% on-site

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Quality Engineer I, Biologics Analytical Services will provide technical and regulatory expertise to the management of all Quality processes to ensure patient safety, regulatory compliance, and inspection readiness. The Quality Engineer works with cross-functional teams to drive continuous improvement in biotechnological manufacturing and development processes.

The role:

• Review and manage quality investigations including OOS, OOT, anomalous events, and deviations from biologics manufacturing.
• Evaluate issues for risk, assess product history, and identify trends or potential root causes.
• Collaborate with cross‑functional teams to resolve investigations and determine business or regulatory impact.
• Identify and support corrective and preventive actions (CAPAs) to drive investigation closure.
• Ensure investigations and required reports are completed accurately and within required timelines.
• Review processes, procedural changes, and materials for compliance with FDA, MHRA, WHO, QSR/cGMP, ISO, and other regulatory requirements.
• Provide technical input for deviations, non‑conformances, and overall quality system improvements.
• Represent the company during regulatory inspections and ensure inspection readiness.
• Communicate clearly with internal and external partners and maintain strong organizational and prioritization skills.

The candidate:

• BS or BA in Related Field and 3+ years of Scientific or Quality Assurance/Quality Control Experience
• Experience in US FDA GMP, ISO standards, as well as, comparable international regulatory agency requirements for investigations
• Experience in regulated industry and laboratory analysis
• Experience with ownership of Quality sub-systems
• Strict attention to detail required.
• Excellent problem-solving skills.
• Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring p