• Job Title: Process Validation Specialist
• Location: Melbourne.Australia
• Type: Full-Time/ContractJOB OVERVIEW:The Process Validation Specialist is responsible for the Operational Qualification (OQ) of process equipment, particularly in protein processing, fractionation, and bulk filling operations. This role ensures that all processes are validated according to industry standards and regulatory requirements, maintaining the integrity and quality of the final product.KEY RESPONSIBILITIES:
• Operational Qualification (OQ):
• Lead and execute Operational Qualification (OQ) activities for process equipment, focusing on filling and protein processing operations.
• Develop and review OQ protocols and reports to ensure they meet regulatory requirements and company standards.
• Coordinate with cross-functional teams, including manufacturing, engineering, and quality assurance, to ensure successful OQ execution.
• Process Equipment Validation:
• Validate and qualify process equipment used in protein processing, fractionation, and bulk filling operations.
• Ensure that all process equipment operates according to design specifications and is capable of consistently producing high-quality products.
• Monitor and analyze equipment performance during OQ to identify and resolve any issues or deviations.
• Protein Process Validation:
• Oversee the validation of protein processing procedures, ensuring the robustness and reproducibility of processes that affect the quality and stability of protein products.
• Conduct risk assessments and identify critical process parameters (CPPs) and critical quality attributes (CQAs) specific to protein processing.
• Collaborate with R&D and process development teams to integrate new protein processes into commercial production.
• Fractionation & Bulk Filling:
• Lead the validation of fractionation and bulk filling processes to ensure that they meet all quality and regulatory standards.
• Develop and implement validation strategies for fractionation processes, including the separation and purification of protein products.
• Validate bulk filling operations to ensure that final products are filled accurately and consistently, maintaining sterility and product integrity.
• Documentation & Compliance:
• Prepare, review, and maintain detailed validation documentation, including protocols, reports, risk assessments, and change controls.
• Ensure that all validation activities comply with relevant regulations (e.g., FDA, EMA) and industry standards (e.g., cGMP).
• Participate in audits and inspections by regulatory bodies, providing validation documentation and responding to inquiries.
• Continuous Improvement:
• Identify opportunities for process improvements based on validation data and trends.
• Work with process engineers and production teams to implement changes that enhance process efficiency, product quality, and compliance.
• Stay current with industry trends, regulatory updates, and best practices related to process validation and protein processing.

QUALIFICATIONS:

• Education:
• Bachelor’s degree in Engineering, Biotechnology, Biochemistry, or a related field. An advanced degree is a plus.
• Experience:
• Minimum of 5-7 years of experience in process validation, particularly in OQ for process equipment, protein processing, and bulk filling.
• Strong experience in the pharmaceutical or biotechnology industry, with a focus on protein fractionation and processing.
• Proven track record of successfully leading OQ projects and process validation initiatives.
• Skills:
• In-depth knowledge of protein processing, fractionation, and bulk filling processes.
• Strong understanding of validation principles, regulatory requirements, and industry guidelines (e.g., cGMP, FDA, EMA).
• Excellent project management and organizational skills.
• Strong analytical and problem-solving abilities, with attention to detail.
• Effective communication and collaboration skills, with the ability to work cross-functionally.
• Proficiency in using validation and quality management software.

Please refer the Job description for details