Catalent
Biologics Manufacturing
QualityEngineerI,BiologicsAnalyticalServices
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Quality Engineer I, Biologics Analytical Services at Catalent. Skills: Quality investigations, Regulatory compliance, CAPA management. Review quality investigations. Manage quality investigations”
What You'll Achieve.
Ensure patient safety; Ensure regulatory compliance; Ensure inspection readiness; Drive continuous improvement; Drive investigation closure
Industry & Context.
Problem-solving skills
100% on-site
What They're Looking For.
Must Have
BS or BA in Related Field, 3+ years Scientific or QA/QC Experience, Experience in US FDA GMP, Experience in ISO standards, Experience in international regulatory agency requirements for investigations, Experience in regulated industry, Experience in laboratory analysis, Experience with ownership of Quality sub-systems
What You'll Do.
Review quality investigations
Manage quality investigations
Evaluate issues for risk
Assess product history
Identify potential root causes
Collaborate to resolve investigations
Determine business impact
Determine regulatory impact
Drive investigation closure
Ensure investigations are completed accurately
Ensure reports are completed accurately
Ensure investigations are completed within timelines
Ensure reports are completed within timelines
Review processes for compliance
Review procedural changes for compliance
Review materials for compliance
Provide technical input for deviations
Provide technical input for non-conformances
Provide technical input for quality system improvements
Represent company during inspections
Ensure inspection readiness
How You'll Work.
Team & Collaboration
Cross-functional teams
Communication Scope
Clear communication
Full Job Description
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 regulat
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