Senior Validation Specialist

Catalent

Saint Petersburg,FL  

2019-10-04 2019-11-03
pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

Position Overview:



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











Position Summary







The Senior 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!







Our Senior Validation Specialist is involved in designing, executing and concluding validation studies as they pertain to Installation, Operational and Performance Qualifications of computer, equipment, facilities and utilities, as well as process and cleaning validations. This person is the designee for the Validation Manager. Assists in the validation program design approach, reviews industry and regulatory standards to ensure the validation program compliance and implements continuous improvement to the validation program.







The Role





+ You will be designing, authoring, reviewing, approving, executing and concluding studies mainly related to process validations but may also include equipment and cleaning validations



+ You will compile, analyze, tabulate and prepare statistical charts and analysis of the data



+ You will assist n the validation program design approach, reviews industry and regulatory standards to ensure the validation program compliance and implements continuous improvement to the validation program



+ You will be managing and coordinating cross-functional activities with product Development, Customers, QA, Engineering, Technical Services, Operations and QC during the execution of aforementioned protocols and a validation trade



+ You will lead project management and coordination of validation activities to ensure projects are completed on time



+ You will serve as validation liaison in Validation Manager’s absence









The Candidate





+ 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 preferred.



+ Strong knowledge of statistical analysis using MiniTab. Knowledge of pharmaceutical manufacturing processes and cGMP with technical writing skills.



+ Strong knowledge of at least two validation trades (cleaning, computer, equipment, facilities, utilities or process validation).



+ Solid communication skills both oral and written and presentation skills.



+ Project Management Skills



+ 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









Position Benefits





+ 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



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ 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.







personal initiative. dynamic pace. meaningful work.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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





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!







personal initiative. dynamic pace. meaningful work.







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.
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