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Validation Engineer

2 months ago

Hollywood, United States The Staffing Resource Group Inc Full time
Validation Engineer

Title: Validation Engineer
Location: Davie, FL
Industry: Pharmaceutical
Shifts Available: Day shift, Monday-Friday, 8am-5pm with occasional local travel to other sites
Salary: Up to $42.50/hr.
Employment Type: Up to1 year contract with possible extension

Environment:
Our client is a global leader in generics and biopharmaceuticals, improving the lives of patients across the world. Today, our portfolio of around 3,500 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of our quality medicines every day. We invest in research and development of generic medicines and biopharmaceuticals, carrying on the legacy of more than a century of finding new ways to help patients improve their lives.

Position Summary:
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.

Core essential skills set to the considered for the role:

  • Technical knowledge of computerized system/equipment preferably oral dosage manufacturing; facilities and utilities; familiar with GAMP, CFRPart11 requirements,
  • Good oral and written communications in English
  • Works independently with minimal supervision
  • Able to write protocol deviations and identify root cause and corrective actions
  • Master s or Ph.D. in Science, Engineering or pharmacy required (Chemical, biomedical or Mechanical preferred)
  • 2-5 years of experience within pharmaceutical or related manufacturing facility
  • Experience in a manufacturing environment within pharmaceutical.
Responsibilities:
  • Reviews electrical, mechanical, and software/computer specifications in manufacturer and blueprint form and identifies critical parameters.
  • 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.
  • Assures that protocols are approved through proper channels; writes and revises validation protocols.
  • Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met.
  • Assures that all test data is gathered and recorded in accordance with cGMP requirements.
  • Writes final reports and assures that they are approved through proper channels.ps and communicates
  • Develops and communicates project timelines and status.
  • Complies with all GMP and safety requirements, SOP s and Company policies and procedures.
  • Performs related duties as assigned.
  • 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.
  • Receives instruction, guidance and direction from others.
  • Position Requirements: Bachelor s in engineering required (Chemical or Mechanical preferred)
  • 2-5 years of experience within pharmaceutical or related manufacturing facility
  • Experience in development and execution of qualification protocol/reports as related to automated equipment/systems preferred.
  • Concise and organized writing of technical data
  • Works with multiple departments to gather and summarize findings
  • Understands manufacturing equipment functional parts including control systems, mechanical components, and electrical power.
  • Responding to common inquiries or complaints from internal customers, regulatory agencies and management.
  • Interpreting software changes, diagrams and flowcharts, design drawings (blueprints) and/or construction drawings and specifications including but not limited to HVAC, CA, Water Systems.
  • Communicating clearly and concisely, both orally and in writing.
  • Strong technical writing skills, Mechanical and electrical concepts.
  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and related federal, state and local laws codes, regulations and regulatory requirements.
  • Principles and practices of qualification and validation.
  • Techniques and principles of sampling, testing and measuring mathematical calculations.
  • Personal computer operations and Microsoft applications (Word, Access, excel, Powerpoint, Projects and Visio).
  • Ensuring compliance with all company policies and procedures, including safety rules and regulations


SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

EOE/ADA