Senior Quality Engineer

Senior Quality Engineer Position Summary:

Work Schedule:

Monday - Friday, 8:00am to 5:00pm 100% on-site The Morrisville (MSV) facility is Catalent's center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. The Senior Quality Engineer is responsible for ensuring compliance with quality standards and regulatory requirements through effective oversight of deviations, laboratory investigations, and Corrective and Preventive Actions (CAPAs). This role requires extensive experience, sound judgment, and the ability to lead quality improvement initiatives.

The Role:

Review, approve, and provide guidance on deviations, ensuring thorough root cause analysis and appropriate corrective actions Lead and support laboratory investigations to ensure accuracy, completeness, and compliance with internal procedures and regulatory expectations Evaluate and approve CAPAs for effectiveness, sustainability, and alignment with quality systems Monitor and analyze quality data to identify negative trends and drive continuous improvement initiatives Proactively recommend and implement process improvements to enhance product quality and operational efficiency Collaborate cross-functionally with manufacturing, quality control, and regulatory teams to resolve quality issues Other duties as assigned

The Candidate:

Must have a bachelor's degree. Preferably in Chemistry, Engineering or Pharmaceutical Science Minimum of 8+ years of relevant experience in the pharmaceutical industry, specifically within a Quality function role is required Strong knowledge of deviation management, investigations, and CAPA systems with Strong communication and leadership abilities is required Must have knowledge of cGMP, GLP, ICH, and compendial regulations or guidelines Experience writing, amending and auditing Standard Operating Procedures is required Strong expertise across multiple dosage forms, with a preference for nasal spray formulations is preferred Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds Why you should join

Catalent:

Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! 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 process. Notice to

Agency and Search Firm Representatives:

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S.

Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE. 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.