Drug Product Validation Expert

7 days ago

Melbourne, Victoria, Australia beBeeValidation Full time $100,000 - $140,000
Drug Product Validation Expert

We are seeking a skilled Drug Product Validation Expert to join our team. As a key member of our operations group, you will be responsible for ensuring the quality and integrity of our drug products.

  • Lead the development and implementation of validation strategies for new and existing drug product manufacturing lines.
  • Develop and maintain comprehensive documentation, including validation reports, protocols, and procedures.
  • Collaborate with cross-functional teams to ensure seamless integration of validation activities into our overall operations.
  • Identify and implement opportunities for process improvements and efficiency gains in validation workflows.
  • Ensure compliance with regulatory requirements, industry standards, and internal policies and procedures.

Key Responsibilities:

  • Develop and execute validation plans for new equipment, processes, and systems.
  • Conduct risk assessments and perform root cause analysis to identify and address potential validation issues.
  • Provide training and guidance to colleagues on validation best practices and procedures.
  • Maintain accurate and detailed records of validation activities and results.
  • Communicate validation status and outcomes to stakeholders, including management, regulatory agencies, and customers.

Requirements:

  • Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
  • Minimum 3-5 years of experience in pharmaceutical or biotech industry, with focus on sterile manufacturing operations.
  • Strong understanding of GMP regulations and industry standards.
  • Excellent communication, interpersonal, and project management skills.
  • Ability to work effectively in a fast-paced environment and prioritize multiple tasks and projects.

Preferred Qualifications:

  • Demonstrated expertise in process validation principles and statistical analysis techniques.
  • Experience with creating and delivering training programs.
  • Knowledge of Lean and Six Sigma principles and their application in process improvement.
  • Familiarity with data management systems and analytical software tools.
  • Fluency in English and proficiency in MS Office applications.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.

About Us:

We are a leading biopharmaceutical company dedicated to delivering innovative medicines to patients worldwide. Our mission is to improve health outcomes by advancing mRNA technology and developing novel treatments for diseases. We value diversity, inclusivity, and teamwork, and strive to create a workplace where everyone can thrive and contribute to our shared success.

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