Catalent Pharma Solutions Validation Specialist in St. Petersburg, Florida

Job Description

The Validation Specialist reports to the Manager, Validation.

St. Petersburg is our primary softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Validation Specialist Position is involved in designing, executing and concluding qualification studies as they pertain to Installation, Operational and Performance Qualifications regarding various forms of equipment and utility systems, as well as writing SOPs where applicable. The Validation Specialist is also responsible for coordinating all validation activities with internal departments, while providing customer service and support to the manufacturing process.

If you would like to be part of a global drug development and delivery leader, then this role might be for you!

The Role

  • Assuring that all activities are performed in compliance with approved validation/qualification protocols, standard operating procedures (SOPs), both Catalent and Technical Support/Validation Departmental policies, and current regulatory requirements/guidelines.

  • Author validation documentation including, but not limited to, Installation, Operational and Performance Qualification protocols and reports, Process Validation protocols and reports, Cleaning Validation protocols and reports, and Protocol Discrepancies and Addenda.

  • Document testing results in validation/qualification protocols per protocol requirements; obtain samples to be analyzed per qualification/validation protocol requirements.

  • Assure that all validation activities are performed in compliance with approved validation/qualification protocols, standard operating procedures (SOPs), both Catalent and Technical Support/Validation Departmental policies, and current regulatory requirements/guidelines.

    The Candidate

  • Bachelors degree in Science or Engineering preferred

  • Minimum of 2 to 5 years experience in the pharmaceutical industry; or 7 years of relevant Validation experience working in the regulated industry.

  • Strong written and oral communication skills.

  • Familiar with Microsoft Word and Excel. Knowledge of pharmaceutical manufacturing processes and cGMP

  • Ability to train and transmit information to co-workers

Position Benefits

  • Cross functional exposure to other areas of Operations

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually + 7 paid holidays

We will identify candidates based on the following Catalent Competencies:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.

Catalent. More products. Better treatments. Reliably supplied. ™

Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

Grow with us. Be challenged. Make a personal impact.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.