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