Catalent

Validation Engineer, Equipment

Catalent

Greenville, NC, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

Are you a meticulous and detail-oriented individual with a passion for ensuring the safety and quality of pharmaceutical equipment? Are you looking for an opportunity to put your technical expertise to use in a fast-paced and dynamic environment? Then we have the perfect role for you! Join our team at Catalent as a Validation Engineer, Equipment and play a crucial role in ensuring the accuracy and compliance of our equipment used in manufacturing life-saving medications. In this role, you will have the opportunity to work alongside a team of highly skilled professionals and take on challenging projects that will contribute to the overall success of our company. If you have a strong understanding of validation principles and experience in the pharmaceutical industry, we would love to hear from you.

  1. Conduct equipment validation activities in compliance with FDA guidelines and company standards.
  2. Develop and execute validation protocols for new equipment and processes.
  3. Collaborate with cross-functional teams to ensure equipment and processes meet all necessary requirements.
  4. Perform risk assessments and identify areas for improvement in equipment and processes.
  5. Troubleshoot equipment issues and provide solutions to ensure safety and quality.
  6. Review and analyze data from equipment validation tests to ensure accuracy and compliance.
  7. Maintain up-to-date knowledge of regulatory requirements and industry best practices.
  8. Participate in equipment qualification and maintenance activities.
  9. Develop and maintain validation documentation, including protocols, reports, and standard operating procedures.
  10. Train and mentor junior team members on equipment validation procedures and techniques.
  11. Communicate effectively with internal stakeholders and external partners regarding equipment validation activities.
  12. Continuously evaluate and improve validation processes and procedures.
  13. Identify and implement cost-effective solutions for equipment validation.
  14. Ensure equipment and processes are in compliance with company quality standards.
  15. Keep detailed records of all validation activities and prepare reports for management.
  16. Participate in audits and inspections to ensure compliance with regulatory requirements.
  17. Monitor and report on equipment performance and recommend improvements as needed.
  18. Adhere to all safety protocols and promote a safe working environment.
  19. Maintain a high level of organization and attention to detail in all validation activities.
  20. Continuously seek opportunities for professional development and stay updated on industry advancements and trends.
Where is this job?
This job is located at Greenville, NC, USA
Job Qualifications
  • Bachelor's Degree In Engineering Or A Related Field: A Validation Engineer At Catalent Should Possess A Strong Educational Background In Engineering Or A Related Field To Have A Solid Understanding Of Technical Concepts And Principles.

  • Previous Experience In Equipment Validation: Candidates Should Have At Least 2-3 Years Of Experience In Equipment Validation In A Pharmaceutical Or Biotech Manufacturing Environment. This Experience Will Demonstrate Their Understanding Of Regulatory Requirements And Industry Best Practices.

  • Knowledge Of Fda Regulations And Guidelines: A Validation Engineer At Catalent Should Have A Thorough Understanding Of Fda Regulations And Guidelines Such As Cgmp, 21 Cfr Part 11, And Annex 11. This Knowledge Is Essential For Ensuring Equipment Compliance And Maintaining Product Quality And Safety.

  • Attention To Detail And Strong Analytical Skills: As A Validation Engineer, Attention To Detail Is Critical To Ensure Accurate And Precise Testing And Documentation. Candidates Should Also Have Strong Analytical Skills To Interpret Data And Troubleshoot Any Issues That Arise During The Validation Process.

  • Strong Communication And Teamwork Skills: Validation Engineers At Catalent Work In A Team Environment And Collaborate With Various Departments And Stakeholders. Effective Communication And Teamwork Skills Are Necessary To Ensure Successful Completion Of Validation Projects And To Maintain Positive Working Relationships.

Required Skills
  • Documentation

  • Quality Assurance

  • Validation

  • Troubleshooting

  • Data Analysis

  • Root Cause Analysis

  • Risk assessment

  • Process optimization

  • GMP compliance

  • Equipment validation

  • Calibration

  • Test Protocols

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • flexibility

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Validation Engineer, Equipment in Greenville, NC, USA is between $70,000 and $110,000 per year. This salary range can vary based on factors such as years of experience, industry, and company size.

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 PostedDecember 19th, 2023
Apply BeforeJune 21st, 2025
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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.

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