Technical Services and Validation Specialist II (Jupiter)

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.

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