Catalent Pharma Solutions Inc

Computer Systems Engineer

Catalent Pharma Solutions Inc$70K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Computer Science or equivalent experience
  • Minimum 1 year of hands-on IT support experience
  • Desired experience with laboratory and analytical systems
  • Working knowledge of Microsoft Azure and Windows environments
  • Proven problem-solving and analytical skills
  • Effective communication and collaboration skills
  • Ability to perform physical tasks in a manufacturing environment

Responsibilities

  • Support development and delivery of computerized systems in the Biologics Department
  • Enhance existing computer system validation programs
  • Draft, review, execute, and approve Computer System Validation protocols and reports
  • Act as Subject Matter Expert for Computer System Validation
  • Manage changes to computerized laboratory systems through change control
  • Troubleshoot and maintain computerized laboratory control systems
  • Respond to customer and regulatory audit observations

Benefits

  • Career growth with clear paths and regular performance reviews
  • Day-one benefits including medical, dental, and vision
  • 401(k) match and tuition reimbursement
  • Paid time off totaling 152 hours plus 8 holidays
  • Inclusive culture with Employee Resource Groups
  • Discounts from 900+ merchants via Perkspot
  • Mission-driven workplace that helps save lives
Full Job Description
Computer Systems Engineer

Position Summary:

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


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 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.
  • 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.


About Catalent Pharma Solutions Inc

Catalent Pharma Solutions Inc is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. The company operates in four segments: Softgel and Oral Technologies, Biologics, Oral and Specialty Delivery, and Clinical Supply Services. Catalent Pharma Solutions serves customers in various industries, including pharmaceuticals, biotechnology, and consumer health. The company was founded in 2007 and is headquartered in Somerset, New Jersey.
Learn more about Catalent Pharma Solutions Inc
Size
14,000 employees
Industry
Founded
2007

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