Senior Validation Specialist

5 days ago

Sydney, New South Wales, Australia beBeeValidation Full time $110,000 - $140,000
Job Title:

Commissioning Qualification Validation Engineer

Job Description:

The Commissioning, Qualification and Validation (CQV) Specialist will be responsible for commissioning, qualifying and validating GxP facilities, equipment and utilities in assigned projects.

Key responsibilities include:

  • Commission, qualify and validate GxP facilities, equipment and utilities
  • Responsible for protocol writing and execution, including drafting, executing, reviewing and approving validation documentation to meet cGMP requirements, regulatory requirements and quality standards
  • Draft and execute validation documentation such as validation project and master plans, requirement specifications, IQ and OQ test scripts, IQ/OQ/PQ protocols and validation summary reports
  • Initiate and coordinate risk analyses, design reviews and execute FAT/SAT, IQ, OQ and PQ
  • Conduct preventative maintenance and perform risk assessments
  • Recommend process improvements where needed to ensure compliance with industry standards
  • Establish validation standards and develop performance testing and quality control measures
  • Execute process equipment and clean room validation
  • Clearly communicate all progress, updates and action steps for assigned projects

Requirements:

  • Bachelor's degree in a relevant science or engineering field, or equivalent years of hands-on experience
  • 3+ years' experience in the biotechnology and pharmaceutical industries with a minimum of 2 years' relevant experience performing CQV activities within a GMP environment
  • 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 is 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

About This Opportunity:

We are looking for a highly skilled Commissioning Qualification Validation Engineer to join our team. The successful candidate will have excellent communication skills and the ability to work independently in a fast-paced environment.

Why Join Our Team:

Our company offers a dynamic and supportive work environment with opportunities for professional growth and development. We prioritize employee well-being and offer a range of benefits and perks to support your physical and mental health.

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