Senior Pharmaceutical Facilities Validation Specialist

2 days ago

Brisbane, Queensland, Australia beBeepharmaceutical Full time $100,000 - $150,000
Job Description:

We seek a senior professional to develop documentation for the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.

The ideal candidate will have extensive experience in performing commissioning and/or qualification activities in an FDA-regulated industry.

Responsibilities include writing and executing protocols (field verification), developing summary reports at client sites, planning/coordinating work, and directing small teams in document development and execution.

  • Develop documentation for the commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.
  • Responsible for protocol writing and execution (field verification) and development of summary reports at client sites.
  • Planning/coordinating work and directing small teams in document development and execution.
Required Skills and Qualifications:
  • Excellent technical problem-solving and troubleshooting skills with solid knowledge of typical project technical issues.
  • High attention to detail.
  • Ability to multitask and take initiative to accomplish assigned tasks accurately by established deadlines.
  • Ability to work independently while quickly building and nurturing a project team.
  • Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
  • Support onsite and offsite activities such as FATs, SATs, IOQ and PQ Executions and System Walkdowns.
  • Experience in planning/directing C&Q activities.
  • Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Benefits:

We offer a highly competitive salary, continuing education opportunities, cutting-edge projects in a rapidly evolving field, comprehensive health insurance coverage aligned with local regulations, paid time off, ESOP/401K company contributions, company-paid life assurance, company-paid income protection/long-term disability, career/professional development opportunities, and additional benefits/leave entitlements based on local regional requirements.

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