Technical Services and 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:

· Bachelor’s 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:

o GMP Documentation and Compliance

o Understanding of FDA regulations

o Understanding of OSHA regulations

o 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