Quality Engineer, Validation II

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 70,000 - 90,000; Full time

Job summary

Catalent Pharma Solutions is seeking a Quality Engineer, Validation II, to ensure high-quality processes in their Kansas City facility. This full-time position involves overseeing validation documentation, driving process improvements, and ensuring compliance with regulatory standards. Join a leading company dedicated to enhancing lives through innovative drug delivery solutions.

Benefits

Defined career path and annual performance review

Diverse, inclusive culture

Medical, dental and vision benefits effective day one

Tuition Reimbursement

Generous 401K match

Community engagement and green initiatives

Qualifications

• At least three years of validation experience required.
• Clear understanding of related GMPs.
• Ability to communicate clearly with internal and external clients.

Responsibilities

• Oversee development of validation documentation.
• Drive process improvement using quality engineering tools.
• Review and ensure compliance with FDA QSR/cGMP and ISO.

Skills

Problem Solving

Quality Engineering Tools

Communication

Education

Bachelor’s degree in engineering or scientific discipline

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.

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, 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 SOP's that meet all applicable regulatory requirements
• All other duties as assigned

The Candidate:

• Bachelor’s 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 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 [e-mail]. 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 [e-mail] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.