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

I. Department Overview:

The Validation Department is responsible for all aspects of the validation program. This includes equipment qualification, process evaluation and process validation, cleaning validation and computer validation.

II. Basic Function:

Validation Specialist Position involves 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.


III. Specific Activities, and

Responsibilities:
  • Designing, executing and concluding studies that pertain to process and cleaning validations.

  • Participating in the execution of scale-up and demonstration studies, and coordination of validation activities as they pertain to specific projects

  • Providing guidance and training to the QC Laboratory and Operations Department for assisting in the execution of qualification/validation related testing.

  • Coordinating cross-functional activities with QA, Engineering, Technical Services, Operations and QC during the execution of aforementioned protocols.

  • 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.

  • Coordinate all validation activities with internal departments, while providing customer service and support to the manufacturing process.

  • Coordinate all validation activities with external (client) departments, while providing customer service.

  • 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.

  • Maintain and organize data associated with the execution of qualification/validation related activities.

  • Compile and tabulate data to be presented in report form.

  • Provide the QC Laboratory with Test Request Forms upon sample submission for testing.

  • Serve as validation liaison in Validation Manager's absence.

  • Serve as Validation Project Lead in assigned projects.

  • 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.

  • Provide pertinent information/opinion as to the validity of equipment functionality, utility system functionality, a manufacturing process, or cleaning process

IV. Knowledge Requirements:

Education or Equivalent:

  • 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 and Excel. Knowledge of pharmaceutical manufacturing processes and cGMP

Knowledge/Skills Requirements:

  • PC skills, including training on Catalent's software packages.

  • Ability to complete necessary paperwork in a timely manner.

  • Regular attendance but flexible in work hours to accommodate production schedule.

  • Ability to train and transmit information to co-workers

Physical/Mental Requirements:

  • Ability to work effectively under pressure to meet deadlines.

  • Individual may be required to sit, stand, walk, regularly and occasionally lift 0-15 pounds

  • Be accessible to manufacturing floor and office staff and to use required office equipment.

  • 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

Business Environment:

  • Individual's primary workstation is located in the office area where the noise level is low.

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

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
Senior Validation Specialist

Catalent

Posted 3 weeks ago

VIEW JOBS 9/23/2019 12:00:00 AM 2019-12-22T00:00 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. Catalent Saint Petersburg FL

Validation Specialist

Catalent