Senior Pharmaceutical Commissioning Qualification Validation Specialist
6 days ago
CAI is seeking a highly skilled Senior Pharmaceutical Commissioning Qualification Validation Engineer to join our team in Australia. The ideal candidate will have extensive experience in commissioning, qualification, and validation in the pharmaceutical, medical device, or biotechnology industries.
About CAI:
CAI is a 100% employee-owned company established in 1996, with a global presence and a strong reputation for delivering high-quality services. We provide commissioning, qualification, validation, start-up, project management, and consulting services to FDA-regulated and other mission-critical industries.
Position Overview:
We are looking for a Senior CQV Engineer to develop documentation to support Commissioning, Qualifications, and Validation. The successful candidate will be responsible for protocol writing and execution, field verification, and development of summary reports at client sites.
Key Responsibilities:
- Develop comprehensive 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.
- Plan and coordinate work and direct small teams in document development and/or execution.
Requirements:
- BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.
- 5 – 12 years' experience performing commissioning and/or qualification activities in an FDA-regulated industry.
- Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
- High attention to detail.
- Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
- Ability to work independently while quickly building and nurturing a project team.
- 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.
- Expertise in Microsoft Word and Excel.
- Excellent oral and written English are required.
- Able to travel domestically if required.
- Able to work in Australia without sponsorship.
What We Offer:
- Highly Competitive Salary
- Continuing education (internal and external)
- Opportunities to work on cutting-edge projects in a highly evolving field
- 100% Employee Owned
- 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
- Medical / Dental / Vision (In accordance with each countries' applicable regulations)
- Professional Development (Approximately $5,000 paid career-related, continuing education)
- ESOP/401k – 15% Company Contribution
- Company Paid Long-Term Disability
- Company Paid Life Insurance
- Company Paid Parental Leave (In accordance with each countries' applicable regulations)
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