Stefanini Group is hiring!
Stefanini is looking for Validation Technician in Davie, FL
For quick Apply, please reach out to Shubham Singh - call: 248 728 2629 / email: Shubham.Singh@stefanini.com
Work Hours: Mon - Fri (40 hours)
Work Location: Davie, FL
Shift: 1st Shift (8:00 AM - 5:00 PM)
Under general supervision, performs advanced journey-level duties in reviewing specifications and determining the critical aspects of facilities, utilities and computer systems, and manufacturing equipment with regard to product and process quality; prepares qualification protocols; performs technical and specialized engineering duties. Perform and/or provide support to validate equipment for the use in manufacturing and packaging processes. Good interpersonal, organizational, and communication skills (both oral and written) and demonstrated skills leading and working with teams to deliver projects. Introduces, troubleshoots, and audits current processes. Has in-depth understanding of pharmacological, chemical, medical, compliance, legal, and industry factors.
Responsibilities:
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Carries out responsibilities in accordance with the organization's policies, procedures, and state, Federal and local laws.
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Reviews electrical, mechanical, and software/computer specifications in manufacturer and blueprint form and identifies critical parameters.
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Writes protocols (IQ/OQ/PQ) that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
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Assures that protocols are approved through proper channels; writes and revises validation protocols.
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Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
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Assures that all test data is gathered and recorded in accordance with cGMP requirements.
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Writes final reports and assures that they are approved through proper channels.ps and communicates
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Develops and communicates project timelines and status.
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Complies with all GMP and safety requirements, SOP's and Company policies and procedures.
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Performs related duties as assigned.
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Performs periodic reviews of equipment and system qualifications, prepares summary report, and assigns CAPAs to address deficiencies. Includes reviews of change controls, deviations, work orders, IQ/OQ, URS, drawings, and FS/DS as applicable.
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Receives instruction, guidance, and direction from others.
Required:
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Master's or Ph.D. in Science, Engineering or pharmacy required (Chemical, biomedical or Mechanical preferred)
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2-5 years of experience within pharmaceutical or related manufacturing facility.
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Prefer previous experience in a manufacturing environment within pharmaceutical.
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Able to write protocol deviations and identify root cause and corrective actions
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Experience in development and execution of qualification protocol/reports as related to automated equipment/systems preferred.
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Technical knowledge of computerized system/equipment preferably oral dosage manufacture, facilities, and utilities.
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Familiar with GAMP, CFR Part 11 requirements.
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Good oral and written communications in English.
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Works independently with minimal supervision.
Skills:
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Concise and organized writing of technical data
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Works with multiple departments to gather and summarize findings
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Understands manufacturing equipment functional parts including control systems, mechanical components, and electrical power.
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Related experience from other industries considered
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Responding to common inquiries or complaints from internal customers, regulatory agencies, and management.
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Interpreting software changes, diagrams and flowcharts, design drawings (blueprints) and/or construction drawings and specifications including but not limited to HVAC, CA, Water Systems.
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Communicating clearly and concisely, both orally and in writing.
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Strong technical writing skills.
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Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state, and local laws codes, regulations, and regulatory requirements.
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Pharmaceutical principles, practices, and applications.
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Principles and practices of qualification and validation.
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Techniques and principles of sampling, testing, and measuring mathematical calculations.
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Mechanical and electrical concepts.
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English usage, spelling, grammar, and punctuation
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Personal computer operations and Microsoft applications (Word, Access, excel, PowerPoint, Projects, and Visio).
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Ensuring compliance with all company policies and procedures, including safety rules and regulations.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.