Process Validation Specialist
Posted on Jun 14, 2019 by Catalent
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
- 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
- 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
- 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. ™
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C atalent 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 . 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.