Full Time Computer System Validation Csv Jobs (NOW HIRING)

Computer Systems Engineer

Position Summary:

• Work Schedule: Monday - Friday, 8:00am - 5:00pm
• 100% on-site

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.

The position is responsible for supporting the development, growth and delivery of various computerized systems implemented at the Kansas City Biologics Department. The position will play a key role on the implementation teams that will be responsible for defining standard business processes, configuring/testing/validating the software solutions, and deploying the solutions for the Biologics department. The position works closely with the business, consulting partners, and internal IT teams serving as an expert resource.

The Role:

• 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

The Candidate:

• Bachelor's degree in Computer Science or equivalent combination of education, certifications, and experience, with a minimum of 1 year of handson 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 problemsolving 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 crossfunctional teams.
• Physical Requirements & Work Environment: 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. Work is performed in a manufacturing environment with exposure to temperature changes, humidity, noise, vibration, wet conditions, and potential hazards, including occasional exposure to extreme heat or cold.

Why You Should Join Catalent:

• Career growthwith a clear path and regular performance reviews
• Day-one benefits:medical, dental, vision
• 401(k) match, tuition reimbursement, and wellness perks
• Paid time off:152 hours + 8 holidays
• Inclusive culturewith Employee Resource Groups and community initiatives
• Discountsfrom 900+ merchants via Perkspot
• A mission-driven workplacewhere your work helps save lives

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.

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