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Commissioning Qualification Validation Engineer - Job Opportunity at PSC Biotech

Sydney, Australia
Full-time
Mid-level
Posted: July 7, 2025
On-site
AUD 85,000 - 110,000 per year based on the mid-level experience requirements, specialized CQV skillset, and Sydney's competitive life sciences market. This range reflects the premium for GxP experience and the strong demand for validation professionals in Australia's growing biotechnology sector.

Benefits

Comprehensive compensation and benefits structure that rewards performance and recognizes professional contributions
Professional development tools and resources designed to accelerate career growth and industry expertise
Coaching and mentorship programs focused on developing next-generation industry leaders
Global exposure and multicultural team collaboration opportunities spanning North America, Europe, Asia-Pacific and Middle East
Career-focused environment that prioritizes long-term professional growth over transactional employment relationships

Key Responsibilities

Lead commissioning, qualification, and validation activities for GxP facilities, equipment, and utilities, ensuring regulatory compliance and operational excellence across critical biotechnology infrastructure
Drive validation documentation lifecycle management including protocol writing, execution, review, and approval processes that directly impact product quality and regulatory compliance
Develop and execute comprehensive validation documentation including Validation Project & Master Plans, Requirement Specifications, IQ/OQ/PQ Protocols, and Validation Summary Reports that serve as regulatory foundation
Coordinate and execute risk analyses, design reviews, and Factory/Site Acceptance Testing protocols that minimize operational risks and ensure system reliability
Implement preventative maintenance programs and conduct risk assessments that optimize equipment performance and extend asset lifecycle
Identify and recommend process improvements that enhance compliance standards while driving operational efficiency and cost optimization
Establish validation standards and develop performance testing frameworks that ensure consistent quality control measures across all operations
Execute process equipment and clean room validation protocols that maintain sterile manufacturing environments critical to biotechnology production
Facilitate cross-departmental collaboration and project communication, ensuring alignment of validation activities with broader organizational objectives and timelines

Requirements

Education

Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands-on experience

Experience

3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within GMP environment

Required Skills

Sound industry knowledge, project proficiency, and autonomy expected Experienced in CQV of facility/utility/equipment, including PW, HVAC and process or laboratory equipment Understands current risk-based validation approaches Experience in authoring, revising, reviewing, and completing controlled documents for validation projects Experience with system impact assessment and risk assessment Good knowledge of the code of GMP and PIC/S code Previous experience in the Life Sciences Industry is required Previous experience in GxP Industries are required Must be adaptable, customer service oriented, have a positive attitude Excellent organizational skills High attention to detail Must have strong written and verbal communication skills
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Sauge AI Market Intelligence

Industry Trends

The biotechnology and pharmaceutical industries are experiencing unprecedented growth driven by personalized medicine, cell and gene therapies, and advanced biologics manufacturing, creating sustained demand for validation professionals who can ensure regulatory compliance in increasingly complex manufacturing environments. This growth is particularly pronounced in the Asia-Pacific region, where government investments in biotechnology infrastructure and regulatory harmonization with international standards are creating substantial opportunities for CQV professionals. Risk-based validation approaches are becoming the industry standard, replacing traditional validation methodologies with more efficient, science-based approaches that focus resources on areas of highest risk. This shift requires CQV professionals to develop sophisticated risk assessment capabilities and understand how to apply ICH Q9 Quality Risk Management principles to validation activities, making professionals with these skills highly valuable in the current market. The integration of Industry 4.0 technologies, including IoT sensors, real-time monitoring systems, and data analytics platforms, is transforming validation practices in life sciences manufacturing. CQV engineers must now validate not only traditional equipment and systems but also complex digital infrastructure and data integrity systems, requiring expanded technical competencies and understanding of computerized system validation principles.

Role Significance

Typically works within a validation team of 5-8 professionals, collaborating closely with 2-3 other CQV engineers while interfacing with quality assurance, manufacturing, facilities, and regulatory affairs teams. The role often involves leading validation activities for specific projects while reporting to a Senior Validation Manager or Director.
This is a mid-level individual contributor role with significant autonomy and technical responsibility, requiring independent decision-making on validation strategies and serving as a subject matter expert for GxP compliance. The role carries substantial regulatory accountability and requires the ability to influence cross-functional teams while maintaining technical excellence in validation deliverables.

Key Projects

New facility commissioning and qualification projects supporting biotechnology manufacturing expansion, including clean room validation, utility system qualification, and equipment commissioning for bioreactor systems, purification equipment, and fill-finish operations Technology transfer validation activities supporting the establishment of manufacturing capabilities for new therapeutic products, requiring comprehensive validation of manufacturing processes, analytical methods, and quality control procedures Remediation and re-validation projects addressing regulatory findings or supporting facility upgrades, involving risk assessments, gap analyses, and implementation of enhanced validation protocols to ensure continued compliance with evolving regulatory requirements

Success Factors

Deep understanding of regulatory requirements and ability to translate complex GxP regulations into practical validation strategies that ensure compliance while supporting business objectives. Success requires staying current with evolving regulatory guidance and maintaining expertise in both traditional and emerging validation approaches. Strong project management capabilities combined with technical expertise to manage multiple validation projects simultaneously while maintaining attention to detail and meeting critical timelines. The ability to balance competing priorities and communicate effectively with stakeholders at all levels is essential for success in this role. Collaborative leadership skills that enable effective cross-functional teamwork and the ability to influence without direct authority. Success requires building strong relationships with manufacturing, quality, and regulatory teams while maintaining the independence necessary to make objective validation decisions. Continuous learning mindset and adaptability to evolving technologies and regulatory landscapes. The biotechnology industry's rapid pace of innovation requires CQV professionals who can quickly understand new technologies, assess their validation requirements, and develop appropriate qualification strategies.

Market Demand

High demand driven by Australia's significant investment in biotechnology infrastructure, the establishment of new manufacturing facilities following supply chain disruptions, and the ongoing need for validation expertise to support both established pharmaceutical operations and emerging biotech companies in the region.

Important Skills

Critical Skills

GxP compliance expertise and understanding of current Good Manufacturing Practice requirements are fundamental to success in this role, as all validation activities must ensure regulatory compliance and support successful regulatory inspections. This knowledge directly impacts product approval timelines and commercial success. Risk-based validation methodology expertise is essential as the industry continues to move away from traditional validation approaches toward more efficient, science-based strategies. Professionals who understand how to apply risk assessment principles to validation activities provide significant value to organizations seeking to optimize validation resources while maintaining compliance. Technical writing and documentation skills are critical for creating validation protocols, reports, and regulatory submissions that meet stringent quality standards and support regulatory approval processes. The ability to communicate complex technical information clearly and accurately is essential for regulatory compliance and project success.

Beneficial Skills

Computerized system validation expertise is increasingly valuable as manufacturing operations become more digitized and data-driven. Understanding how to validate software systems, databases, and automated manufacturing equipment provides competitive advantages in the current market. Project management certification and advanced project management skills enhance career progression opportunities and enable more effective leadership of complex validation projects involving multiple stakeholders and tight timelines. International regulatory knowledge and understanding of different regional requirements (FDA, EMA, TGA, PMDA) increases marketability and creates opportunities for global project involvement and international career opportunities.

Unique Aspects

Opportunity to work across diverse biotechnology landscapes and therapeutic areas, providing exposure to cutting-edge manufacturing technologies and validation challenges that enhance professional development and market value
Global project exposure through PSC Biotech's international presence, offering opportunities to work on multinational validation projects and gain experience with different regulatory frameworks and international compliance requirements
Focus on developing next-generation industry leaders through structured coaching and mentorship programs, providing accelerated career development opportunities not typically available in traditional pharmaceutical manufacturing environments
Involvement in establishing validation standards and developing performance testing frameworks, offering opportunities to influence industry best practices and contribute to the advancement of validation methodologies

Career Growth

Career advancement typically occurs within 2-4 years for high-performing professionals, with progression accelerated by successful completion of complex validation projects, development of specialized expertise in emerging technologies, and demonstration of leadership capabilities in cross-functional project environments.

Potential Next Roles

Senior Validation Engineer or Lead CQV Engineer positions involving greater technical complexity and team leadership responsibilities, typically achieved within 2-3 years with demonstrated expertise in complex validation projects and regulatory compliance Validation Manager or CQV Team Lead roles responsible for managing validation teams and validation programs across multiple projects, requiring development of people management skills and strategic validation planning capabilities Regulatory Affairs or Quality Assurance leadership positions leveraging validation expertise to support broader compliance and quality objectives, or specialized roles in computerized system validation or validation consulting

Company Overview

PSC Biotech

PSC Biotech is a specialized life sciences consulting and services company that provides comprehensive validation, regulatory, and quality assurance support to biotechnology and pharmaceutical companies globally. The company has established itself as a trusted partner for life sciences organizations seeking to navigate complex regulatory requirements while maintaining operational excellence in manufacturing and development activities.

PSC Biotech operates as a mid-tier specialized consulting firm with a strong reputation in the life sciences industry, competing effectively with larger consulting organizations by offering specialized expertise and personalized service delivery. The company's global presence and focus on life sciences validation creates competitive advantages in serving both established pharmaceutical companies and emerging biotech organizations.
The Sydney office represents PSC Biotech's strategic expansion into the Asia-Pacific region, positioning the company to serve Australia's growing biotechnology sector and provide regional support for multinational pharmaceutical companies establishing operations in the region. This location offers excellent opportunities for career growth as the company expands its regional presence and client base.
PSC Biotech emphasizes professional development and career growth, creating an environment where validation professionals can develop expertise while working on diverse projects across multiple therapeutic areas. The company's focus on coaching and developing industry leaders suggests a collaborative culture that values knowledge sharing and professional advancement.
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