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Senior Validation Engineer

4 months ago

Bloomington, United States Catalent Pharma Solutions Full time

Senior Validation Engineer – Cleaning

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Senior Validation Engineer – Cleaning leads the efforts in validating cleaning processes and works closely with operations to ensure swab qualifications are completed. The Senior Validation Engineer will also work closely with other departments and with clients to ensure accurate review of documentation and serves as the point of contact to ensure appropriate cleaning.

This is a fulltime role working days; Monday – Friday and requires flexibility to meet business needs.

There is a $10,000 sign on for this role.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

  • Execute validation protocols for cleaning method validation and cleaning process validation / revalidation
  • Support equipment holds and releases for cleaning
  • Compile data for qualification reports; complete and review calculations and perform technical review of validation documents
  • Lead investigations, change controls, and similar activities
  • Perform cleaning validation carryover and limit calculations; Leads the execution of analytical method validation for cleaning recovery methods (rinse and swabs)
  • Trains and qualifies personnel on cleaning swabbing methods, presents qualifications to clients, auditors, and inspectors
  • Coordinate with other internal groups including QC, engineering, automation, and production to complete execution of validation protocols and other tasks
  • Demonstrate familiarity with industry guidance documents for cleaning validation
  • Execute validation tasks and projects to achieve project timelines
  • Develop qualification strategies and documents for novel systems and products
  • Train new team members and provide technical oversight of work performed by Technicians, Associate Engineers and/or Engineers
  • Demonstrates a strong understanding of guidance documents from FDA, EMA, PDA, ISPE, ASME, ISO, and other industry organizations
  • Participates in response to regulatory requests and observations

The Candidate

  • Bachelor's degree or higher in STEM discipline, required
  • Master's degree or higher, preferred
  • 7+ years of experience in Validation or related discipline, preferred
  • 2 years GMP or other regulated industry experience, required
  • Must be able to read and understand English-written job instructions and safety requirements.

Why You Should Join Catalent

  • Competitive medical benefits and 401K
  • 152 hours of PTO + 8 Paid Holidays
  • Dynamic, fast-paced work environment
  • Opportunity to work on Continuous Improvement Processes

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 ) .