Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
The Process Validation Specialist reports to the Validation Manager.
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.
If you enjoy a fast pace environment, solving problems and working on projects is your passion; and you would like to be part of a global drug development and delivery leader, then this role is for you!
The Process Validation Specialist will be writing and executing process validation protocols and writing final reports, writing validation/process/product assessments to support quality investigations and performing statistical analysis of Critical Process Parameters and product Critical Quality Attributes.
Lead process validations and process confirmations for new products introductions, transferred products and product/process changes;
Lead Continuous Process Verification (CPV) studies;
Review and approve process and product development documents (i.e. batch records, procedures, IPC recipes, etc.);
Provide technical consultation for quality investigations and customer complaints;
Perform process data statistical analysis, statistical process control and process capability analysis;
Collaborate and contribute with other functions to successfully perform process validations, address client and regulatory requirements. This involves collaboration with within R&D, Technical Services, Validation, Manufacturing, Quality Assurance, Quality Control, and Customer Subject Matter Experts;
Support section leaders, project managers, Lean Six Sigma initiatives, and other department-related tasks as requested by supervisor.
Bachelors degree in Science or Engineering preferred and a minimum of 2-5 years experience in the pharmaceutical industry; or 7 years of relevant Validation experience working in the pharmaceutical industry
Strong written and oral communication skills
Familiar with Microsoft Word, Excel and MiniTab Software with special knowledge on SPC, PCA, ANOVA, DOE. Knowledge of pharmaceutical manufacturing processes and cGMP
Ability to work effectively under pressure to meet deadlines
Vision requirements include ability to differentiate color, have 20/30 vision in each eye with or without corrective lenses, read written documents and frequent use of a computer monitor
Work independently and in a project team environment, ability to train and transmit information to co-workers
Cross functional exposure to other areas of Operations
Medical, Dental, Vision and 401K are all offered from day one of employment
152 hours of PTO annually
We will identify candidates based on the following Catalent Competencies:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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. More products. Better treatments. Reliably supplied.
Visit www.catalent.com/careers to explore career opportunities.
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, protected veteran status, sexual orientation or gender identity. 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 DisabilityAccommodations@catalent.com. 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.