Engineer - Quality Validation, Lab Systems

2 months ago

Madison, Wisconsin, United States Catalent Pharma Solutions Full time

The Engineer - Quality Validation, Lab Systems role is responsible for the installation and support of new and existing laboratory systems (equipment and instrumentation) with a focus on computerized systems. The position will effectively communicate with appropriate departments regarding laboratory system performance and work with Vendors, Automation Engineers and/or local IT to ensure proper system function and troubleshoot system concerns.

The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

The Validation group has oversight of the validation program, including commissioning and qualification, cleaning validation, and computer system validation as well as the activities required to maintain systems in a qualified and/or validated state, including change control, requalification, and system reviews.

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The role:

  • Lead and/or collaborate on new and existing laboratory equipment and instrument installations with a focus on software installation, configuration, and administration.
  • Responsible for system administration; including but not limited to,, setting up user accounts, permissions, and passwords, and performing periodic audit trail and user account review.
  • Oversee/coordinate/schedule activities with Vendors, Automation Engineers and/or local IT to ensure the appropriate hardware, including workstations, are available and properly installed.
  • Knowledgeable of automation/controls associated with laboratory equipment and instruments.
  • Provide technical assistance to troubleshoot laboratory systems, including working with vendors to quickly address concerns.
  • Support commissioning, qualification, and validation of laboratory systems, and ensure all supporting documentation is complete, timely, and accurate following Good Documentation Practices (GDP).
  • Support writing and/or executing change controls and/or standard operating procedures to support installation of laboratory systems.

The candidate:

  • Bachelor's degree in Engineering, Computer Sciences, Information Systems, or related scientific field or
  • Technical or Associates degree in a computer based or related field with 1-2 years of related work experience or
  • Equivalent combination of training, education, and experience
  • Prior experience with software installation, configuration and administration is required.
  • Prior experience with GAMP/Part 11 compliant systems is preferred.
  • Prior experience with laboratory equipment and instrumentation is preferred.

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 . 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 for us to investigate with local authorities.

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


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