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Technical & Validation Specialist II

Technical & Validation Specialist II

VetioJupiter, FL, United States
13 hours ago
Job type
  • Full-time
Job description

About the job Technical & Validation Specialist II

SUMMARY :

This position is responsible for assisting with all technical services related to validation (process, product, cleaning, and equipment), qualifications, quality assurance, and compliance within the organization. This role requires a deep understanding of manufacturing processes, regulatory requirements, and animal health or pharmaceutical products. The successful candidate will be part of a team responsible for ensuring that all products meet the highest standards of safety, efficacy, and quality.

DUTIES AND RESPONSIBILITIES :

Technical Oversight :

  • Provide technical guidance and support for the development and validation of new and existing animal health products.
  • Collaborate with R&D, manufacturing, and quality assurance teams to ensure seamless product development transitions.
  • Validation Management : Develop and implement validation protocols and procedures to ensure compliance with regulatory standards (e.g., FDA, USDA).
  • Conduct risk assessments and validate processes to ensure product integrity and safety.
  • Draft and perform IQ / OQ / PQ documentation for new equipment

Quality Assurance :

  • Monitor and evaluate product performance through rigorous testing and validation processes.
  • Establish and maintain quality control measures to uphold product standards.
  • Regulatory Compliance : Stay current with industry regulations and best practices, ensuring that all processes and products comply with relevant laws and guidelines.
  • Prepare and submit necessary documentation for regulatory submissions and inspections.
  • Team Leadership :

  • Collaborate with cross-functional teams to enhance overall product quality and performance.
  • Technical Support : Act as the primary point of contact for technical inquiries related to product validation and performance.
  • Provide training and support to clients and stakeholders on product usage and compliance.
  • Performs other related duties as assigned by management.
  • Project Development & Scale-Up
  • Participate in new project meetings from R&D to commercialization
  • Develop and execute process validation plan
  • Cleaning Validation :

  • Lead Vetio Cleaning Validation program
  • Evaluate and revise cleaning validation program, as needed
  • Author cleaning validation SOPs, protocols, and reports
  • Facilitate the execution of cleaning validation with operations and supply chain
  • Ensure cleaning validation program is kept relevant and executed in a timely manner
  • Process Validation :

  • Author or review batch records, as needed
  • Author or review Process Validation Protocols and reports, as needed
  • Ensure all areas of process are communicated to appropriate teams including Quality Control and Operations
  • Performs other related duties as assigned by management.
  • SUPERVISORY RESPONSIBILITIES :

  • This job has no supervisory responsibilities.
  • QUALIFICATIONS :

  • Bachelors degree in a Science related field required.
  • Minimum of 2 years of experience in a technical services or validation role within the animal health or pharmaceutical industry.
  • Strong understanding of regulatory requirements and quality assurance processes.
  • Excellent analytical, problem-solving, and project management skills.
  • Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.
  • Computer skills required :
  • Microsoft Office Suit (Word, Excel, PowerPoint, Outlook)
  • Microsoft Teams
  • ERP Systems (SAP) (preferred)
  • Quality Management Systems (QMS) (preferred)
  • Other skills required :
  • GMP Documentation and Compliance

  • Understanding of FDA regulations
  • Understanding of OSHA regulations
  • Understanding of standard operating procedures (SOPs) and work instructions
  • Ability to read, interpret, and author technical documents (SOPs, batch records, protocols, etc.)
  • Knowledge of safety protocols and PPE usage
  • recblid 66jdfjjf8bboxnnvzvem8kze8ytc3t

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    Validation Specialist • Jupiter, FL, United States

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