Catalent

Computer Systems Validation Engineer

Catalent
Harmans, Severn, MD, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to Catalent – a leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. We are currently seeking a dedicated and experienced Computer Systems Validation Engineer to join our team. In this role, you will play a crucial part in ensuring that our computer systems and software are compliant with regulatory requirements and industry standards. If you have a strong background in computer systems validation and a passion for ensuring quality and compliance, we encourage you to apply. Join us at Catalent and make a difference in the lives of patients worldwide.

  1. Develop and maintain validation protocols and plans for all computer systems and software used within the company.
  2. Execute validation activities, including documentation, testing, and reporting, in accordance with regulatory requirements and industry standards.
  3. Identify and assess potential risks and develop mitigation strategies to ensure compliance and system reliability.
  4. Collaborate with cross-functional teams to ensure that computer systems and software are designed, implemented, and maintained in accordance with validation requirements.
  5. Conduct periodic reviews and audits of computer systems and software to ensure ongoing compliance.
  6. Keep up-to-date with regulatory requirements and industry best practices related to computer systems validation.
  7. Troubleshoot and resolve any issues related to computer systems validation.
  8. Train and educate staff on computer systems validation procedures, practices, and principles.
  9. Participate in the selection and implementation of new computer systems and software, ensuring they meet validation requirements.
  10. Maintain accurate and complete documentation of all validation activities and results.
  11. Communicate effectively with internal and external stakeholders regarding computer systems validation activities and requirements.
  12. Continuously monitor and improve the computer systems validation process to ensure efficiency and effectiveness.
  13. Act as a subject matter expert on computer systems validation during internal and external audits and inspections.
  14. Contribute to the development and implementation of company-wide quality and compliance initiatives.
  15. Demonstrate a commitment to patient safety and product quality in all aspects of the job.
Where is this job?
This job is located at Harmans, Severn, MD, USA
Job Qualifications

  • Bachelor's Degree In Computer Science Or A Related Field: A Degree In Computer Science Or A Related Field Provides The Necessary Foundation For Understanding Computer Systems And Their Validation Processes.

  • Previous Experience In Computer Systems Validation: Ideally, Candidates Should Have At Least 2-3 Years Of Experience In Computer Systems Validation, Preferably In A Pharmaceutical Or Biotech Industry.

  • Knowledge Of Regulatory Requirements: A Strong Understanding Of Regulatory Requirements, Such As Fda Regulations And Gxp Guidelines, Is Essential For Ensuring Compliance In The Validation Process.

  • Technical Proficiency: Candidates Should Possess Strong Technical Skills, Including Knowledge Of Programming Languages, Software Development Processes, And Database Management.

  • Attention To Detail: Computer Systems Validation Requires A High Level Of Attention To Detail, As Even Small Errors Can Have Significant Consequences. Therefore, Candidates Should Have Excellent Problem-Solving Skills And Be Able To Identify And Address Potential Issues In The Validation Process.

Required Skills

  • Quality Assurance

  • Change control

  • Validation protocols

  • Compliance Management

  • Risk assessment

  • Software testing

  • Documentation management

  • System Validation

  • Data Integrity

  • Gxp Regulations

  • Validation Reports

Soft Skills

  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Active Listening

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Computer Systems Validation Engineer in Harmans, Severn, MD, USA is $85,000 - $115,000 per year. However, this can vary depending on factors such as experience, education, and the specific company or industry the engineer is working in.

Additional Information
Catalent is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMarch 13th, 2025
Apply BeforeJuly 20th, 2025
This job posting is from a verified source. 
Reposted
See an issue with this job? Report it to us

Apply with Video Cover Letter Add a warm greeting to your application and stand out!

Upload
About Catalent

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.

Frequently asked questions
More Jobs From Catalent

View All Catalent jobs

Get interviewed today!

JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.

Get Started