Job Summary:
Catalent’s Kansas City facility is home to their Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The position is responsible for supporting the development, growth and delivery of various computerized systems implemented at the Kansas City Biologics Department, playing a key role in defining standard business processes and deploying software solutions.
Responsibilities:
• Works within the Biologics Validation team in the enhancement of existing computer system validation programs for the validation of new and existing laboratory computer systems, including major capital projects and smaller, stand-alone instrument systems.
• Drafts, reviews, executes and approves protocols and reports related to Computer System Validation (CSV).
• Acts as a Subject Matter Expert (SME) for Computer System Validation (CSV).
• Assists and manages laboratory system contractors as required.
• Reviews and approves changes to computerized laboratory systems through the change control program to assess impact on validated software and network systems.
• Monitors, maintains and troubleshoots existing computerized laboratory control and monitoring systems.
• Assists in responding to customer / regulatory audit observations and corrective actions as it pertains to computer system implementation/validation.
• Identifies and implements improvement opportunities for established laboratory computer systems.
• Provides technical assistance and training for personnel as needed.
• All other duties as assigned
Qualifications:
Required:
• Bachelor’s degree in Computer Science or equivalent combination of education, certifications, and experience, with a minimum of 1 year of hands‑on IT support experience.
• Desired experience supporting laboratory and analytical systems in a global environment.
• Working knowledge of Microsoft Azure, Active Directory, Windows environments, O365, and basic networking concepts.
• Demonstrated ability to learn, retain, and apply complex technical information across multiple systems and topics.
• Strong problem‑solving and analytical skills, including the ability to interpret data, identify trends, and initiate, execute, and monitor corrective actions.
• Effective written and verbal communication skills with the ability to follow detailed instructions and collaborate professionally and accurately with supervisors, peers, and cross‑functional teams.
• Ability to perform duties including standing and walking frequently, sitting continuously, and lifting, pushing, and pulling up to 40 lbs; requires occasional kneeling and reaching.
Company:
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions. Founded in 2007, the company is headquartered in Tampa, USA, with a team of 10001+ employees. The company is currently Late Stage.