Quality Engineer II, Validation

Catalent • Kansas City, MO

87d

About The Position

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)

Requirements

• BS or BA in a Scientific or Engineering Discipline.
• 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.
• 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.

Responsibilities

• Work closely with manufacturing, engineering, development, analytics, QC, and technical support to ensure high quality processes are developed and deployed.
• Provide QA oversight of equipment design, equipment qualification, process validation, cleaning validation, computer system validation, metrology, maintenance, and facilities.
• Determine validation and qualification requirements for equipment, novel technologies, and newly designed process equipment and processes.
• Ensure daily operations, processes, and procedures comply with applicable regulations and Quality Policies.
• Develop SOPs that meet all applicable regulatory requirements.
• Drive systematic problem solving and process improvement 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.

Benefits

• 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.
• WellHub- program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree