
Validation Specialist
4 days ago
About Our Team:
We are a group of dedicated professionals with a passion for commissioning, qualification, and validation. We have nearly 700 people worldwide and provide services related to operational readiness to FDA regulated industries.
We put our clients' interests first, we do not stop until it is right, and we will do whatever it takes to get there.
We act with integrity
We serve each other
We serve society
We work for our future.
You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market.
Job Summary:
The role of a CQV Engineer is to support 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.
Key Responsibilities:
- Support 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.
- Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
- Experience in planning / directing C&Q activities.
- Familiarity with Baseline Guide 5 (Second Edition) a plus.
- Expertise in Microsoft Word and Excel.
- Excellent oral and written English required.
- Able to travel domestically if required.
- Able to work in Australia without sponsorship.
Requirements:
- Résumé highlighting relevant science or engineering degree, or equivalent years of hands-on experience.
- 2-7 years' experience performing commissioning and / or qualification activities in an FDA regulated industry.
Benefits:
- Continuing education (internal and external)
- Opportunities to work on cutting edge projects in a highly evolving field
- Comprehensive Health Insurance coverage
- Paid Time Off
- ESOP/401K – Company Contribution (US Only)
- Company Paid Life Assurance
- Company Paid Income Protection/Long-Term Disability
- Career/Professional Development Opportunities
- Additional benefits/leave entitlements based on local regional requirements
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