CSS- Packaging Validation Specialist
Catalent Pharma Solutions, Inc - Kansas City, MO
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Catalent Pharma Solutions (a Blackstone Group company) is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 20 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.
Development of equipment qualification documentation for packaging equipment, including installation/operation qualification, performance qualification, change control, etc.
Creation/revision of Standard Equipment/Instrument Procedures and associated training materials.
Equipment / equipment parts procurement.
Development and administration of package / dosing design drawings based on project requirements.
Provide equipment training and support.
Prepares and completes documentation in compliance with SOPs and cGMP.
Follows safety and manual handling guidelines. POSITION REQUIREMENTS: Education: BS/MS degree in Mechanical/Electrical Engineering or appropriate scientific discipline. Experience: Minimum 5 years (MS) to 10 years (BS) experience in pharmaceutical engineering manufacturing or validation and qualification of pharmaceutical facilities and equipment. Knowledge/Skills: Code of Federal Regulations and CGMPs relating to the field of validation. Statistical programs. Experience in Statistical Analysis preferred. Demonstrated understanding of process and mechanical engineering. Ability to establish clear priorities quickly. Ability to work effectively under pressure, handle multiple projects and meet deadlines. Strong communication skills, able to interface with all levels of the organization. Ability to lead validation project teams. Ability to write technical documents. PC Literate, word processing and spreadsheet software. Supervises: N/A PHYSICAL/MENTAL REQUIREMENTS MATHEMATICAL AND REASONING ABILITY Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to work effectively under pressure to meet deadlines and handle multiple projects. Individual may be required to sit, stand, walk regularly and occasionally lift 0-75 pounds. Be accessible to laboratory and pilot plan area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.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
Primary Location: United States-MO-Kansas City
Organization: Development & Clinical Services
Job Posting: false
Unposting Date: 43170