Commissioning, Qualification, and Validation Engineer

at  Telix Pharmaceuticals EMEA

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

SEE YOURSELF AT TELIX

We are seeking a highly skilled and experienced CQV (Commissioning, Qualification, and Validation) Engineer to join our Technical Services team. The CQV Engineer will play a pivotal role in ensuring that our equipment, systems, and processes within our brand-new radiopharmaceutical production facilities meet the highest standards of safety, quality, and performance. The ideal candidate will possess a strong background in GMP-regulated environments and demonstrate exceptional technical expertise and attention to detail. The CQV Engineer will be reporting to the Production Director.

KEY ACCOUNTABILITIES:

• Initiation:
• Participate in the development of User Requirements Specifications (URS).
• Assist in the selection of equipment and suppliers.
• Define the qualification strategy.
• Commissioning:
• Develop and execute Design Qualification (DQ) protocols, Factory Acceptance Test (FAT), Site Acceptance Test (SAT)
• Conduct and oversee the installation as well as the initial startup and testing of systems and equipment.
• Ensure that systems are installed according to design specifications and operational requirements.
• Perform system testing and troubleshooting during the startup phase, documenting all activities.
• Qualification:
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Verify and document that equipment and systems are installed correctly and operate as intended.
• Participate in collaboration with equipment owners in defining the maintenance strategy.
• Ensure compliance with all regulatory and safety requirements throughout the qualification process.
• Documentation and Reporting:
• Prepare comprehensive documentation for all commissioning, qualification, and validation activities.
• Generate detailed reports and present findings to management and regulatory bodies as required.
• Maintain accurate records of all activities and outcomes.
• Collaboration and Communication:
• Work closely with cross-functional teams, including quality assurance, production, process development & validation to ensure successful project outcomes.
• Facilitate communication and collaboration among team members and stakeholders to achieve project goals.
• Provide training and support to team members on CQV processes and best practices.
• Attend project meetings as equipment qualification expert

EDUCATION AND EXPERIENCE:

• Engineering degree in a relevant field (e.g. mechanical, electrical, chemical,) or equivalent working experience.
• Minimum of 7 years of experience, including 3 years in CQV activities within GMP-regulated environments.
• Good knowledge of GMP regulations and standards, with a proven track record of ensuring compliance in project execution.
• Prior experience in radiopharmaceutical equipment is a plus.

KEY CAPABILITIES:

• Technical Skills: Expertise in installing, troubleshooting and maintaining complex equipment and systems. Familiarity with automation and control systems used in pharmaceutical manufacturing. Knowledge of equipment design and engineering principles.
• Attention to Detail: Meticulously document all CQV activities and ensure compliance with regulatory standards.
• Analytical Thinking: Identify potential issues and develop solutions to ensure compliance and operational efficiency.
• Results-Oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Team Collaboration: Work effectively with cross-functional teams to ensure successful project outcomes.
• Communication Skills: Clearly document processes and communicate effectively with team members and stakeholders.
• Adaptability: Comfortable working in a dynamic environment, adjusting to changing priorities, and taking on new challenges.
• Project Management: Manage multiple CQV projects simultaneously, ensuring adherence to timelines and budgets.
• Continuous Learning: Shows a commitment to ongoing learning and professional development, continually seeking out opportunities to expand knowledge and skills.
• Ethical Behavior: Acts with integrity and demonstrates a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Language Skills: Fluent in English and French
• Proficient in the use of Microsoft Office applications.
  At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
  Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Please refer the Job description for details