Process Validation Specialist

Catalent Saint Petersburg , FL 33701

Posted 5 months ago

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 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.

The Role

  • 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.

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

  • 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

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.

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Client Product Process Trainer Associate Development Program

Fidelity National Information Services

Posted 2 weeks ago

VIEW JOBS 11/26/2019 12:00:00 AM 2020-02-24T00:00 Position Type Full time - Regular Type of Hire Requisition will be sent to PeopleFluent Experience Desired 1+ Years Education Desired Bachelor of Adult Education, Bachelor of Finance Travel Percentage 0% Job Description Are you curious, motivated, and forward-thinking? At FIS you'll have the opportunity to work on some of the most challenging and relevant issues in financial services and technology. Our talented people empower us, and we believe in being part of a team that is open, collaborative, entrepreneurial, passionate and above all fun. Join the 2020 Associate Development Program today! As a 2020 Associate Development Program full-time participant with FIS, you will have the opportunity to participate in team projects, community service activities, professional development seminars and work with a team that is invested in your growth, development, and success; including quarterly performance connects with your manager and bi-annual merit reviews. This two-year full-time program has a start date of June 13, 2020 with a dedicated "Learning Week" where you will; * Learn how to work within a corporate environment * Learn the structure of FIS and options for growth within the organization * Hear from FIS leadership about their journey and participate in senior leader networking opportunities * Build a network of your peers from across the organization About the team: We are a team of professional trainers who deliver high-quality training on FIS products to our clients who are financial institutions including bank and credit unions. We deliver training in a traditional classroom environment and virtual classroom sessions using WebEx. This job role requires presentation skills and confidence speaking in front of small; and on occasion, large audiences via WebEx. The goal of training is to deliver a learning experience that will enable clients to learn and love our products and our people so that they choose to renew their contracts with FIS as their preferred credit and debit card processor. What you will be doing * Collaborate with subject matter experts to learn FIS products as assigned * Collaborate with instructional designers to develop instructor-led training materials * Consult with clients to ensure their training needs are met and align with their strategic business goals * Collaborate with trainers to share best practices and improve the learning experiences for clients * Deliver instructor-led classes in a traditional and virtual training classes What you bring: * Bachelor's degree from job discipline * Proficiency in Microsoft Office Suite * Strong written and communication skills * Adaptability, a drive to learn, and strong problem-solving skills * Ability to work well independently and within a team Added bonus if you have: * Teaching experience What we offer you * Competitive salary and excellent benefits * The chance to work on some of the most challenging, relevant issues in financial services & technology * A broad range of professional education and personal development possibilities – FIS is your final career step! * Time to support charities and give back in your community * A work environment built on collaboration, flexibility and respect Privacy Statement FIS is committed to protecting the privacy and security of all personal information that we process in order to provide services to our clients. For specific information on how FIS protects personal information online, please see the Online Privacy Notice. EEOC Statement FIS is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, genetic information, national origin, disability, veteran status, and other protected characteristics. The EEO is the Law poster is available here supplement document available here For positions located in the US, the following conditions apply. If you are made a conditional offer of employment, you will be required to undergo a drug test. ADA Disclaimer: In developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis. Sourcing Model Recruitment at FIS works primarily on a direct sourcing model; a relatively small portion of our hiring is through recruitment agencies. FIS does not accept resumes from recruitment agencies which are not on the preferred supplier list and is not responsible for any related fees for resumes submitted to job postings, our employees, or any other part of our company. Fidelity National Information Services Saint Petersburg FL

Process Validation Specialist

Catalent