Quality Engineer, Validation II
Quality Engineer, Validation II
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Job Description
Quality Engineer Validation II
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.
Catalents 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 Validation II. The Quality Engineer Validation II will work closely with manufacturing manufacturing engineering development and technical support to ensure high quality processes are developed and deployed.
This is a full-time on-site salary position: Monday Friday 1st shift.
Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.
The Role
- Oversee the development of utility equipment and process validation documentation
- Drive systematic approach in problem solving and process improvement using quality engineering tools
- Work with appropriate parties in providing corrective and preventative actions based on sound engineering analysis
- Review and ensure all process materials and procedural changes are engineering sound and in compliance to all FDA QSR/cGMP ISO and Quality Policies
- Provide manufacturing systems expertise knowledge and leadership in support of production
- Develop systems to identify analyze correct and prevent issues that adversely affect product safety and performance
- Work with operations and facilities to develop SOPs that meet all applicable regulatory requirements
- All other duties as assigned
The Candidate:
- Bachelors degree in engineering or scientific discipline with at least three years of validation experience is required
- Clear understanding of related GMPs
- Adheres to company policy
- Communicated clearly with internal and external clients both verbal and written
- Willingness to contribute to team activities
- Individual may be required to sit stand walk regularly and occasionally lift up to 40 pounds
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 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match
- Company match on donations to organizations
- 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 7000 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 . 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 for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Employment Type
Full-Time
