Quality Engineer ll, Validation

Quality Engineer II, Validation

Position Summary

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.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Quality Engineer II, Validation. The Quality Engineer II, Validation provides review and approval of all Computer System Validation and Equipment Qualification documents for the Kansas City PCH-EP Business, and assists the Associate Director, Quality Assurance in review and approval of Cleaning and Process Validation documents. In addition, Quality Engineer II, Validation will provide quality oversight of Metrology, Maintenance, and Facilities at the site.

This is a full-time, salary, onsite position. This is a 1st shift position. (Monday-Friday 8am-5pm)

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Work closely with manufacturing, engineering, development, analytics, QC, and technical support to ensure high quality processes are developed and deployed.  Activities include QA oversight of equipment design, equipment qualification, process validation, cleaning validation, computer system validation, metrology, maintenance, and facilities.
• Work with operations, engineering, quality, and validation teams to determine validation and qualification requirements for equipment, novel technologies, and newly designed process equipment and processes.
• Work closely with metrology, equipment maintenance, and facilities maintenance to ensure daily operations, processes, and procedures comply with applicable regulations and Quality Policies.
• Work with analytics, operations, maintenance and facilities to develop SOPs that meet all applicable regulatory requirements.
• Drive systematic problem solving and process improvement approach using quality engineering tools including Six
• Sigma, DMAIC, Statistical Process Control, Design of Experiments.
• Review and ensure all process, material, and material changes are engineering sound and in compliance with all
• FDA QSR/cGMP, ISO, and Quality Policies of the company

The Candidate 

• Education or Equivalent: BS or BA in a Scientific or Engineering Discipline
• Experience: 12+ years of Scientific or Quality Assurance/Quality Control or Validation Experience
• Clear understanding of related SOPs, cGMPs and as necessary to accomplish daily tasks;
• Communicates clearly with internal and external clients, both verbal and written
• Good organizational skills relating to management of associates’ daily activities
• Adequate Problem-Solving Skills and Decision-making skills to identify and solve work related issues

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!
• WellHub- program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.