Senior Pharmaceutical Commissioning Qualification Validation Specialist
18 hours ago
CAI is a 100% employee-owned company established in 1996, with a global presence of nearly 700 people. We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness to FDA regulated and other mission-critical industries.
Our approach is centered around putting the client's interests first, ensuring that every project meets the highest standards, and delivering exceptional results.
Our Foundational Principles- We act with integrity
- We serve each other
- We serve society
- We work for our future
As employee owners, we are committed to living these principles both professionally and personally. We prioritize teamwork, respect, and a can-do attitude, which has enabled us to grow exponentially.
Job OpportunityWe are seeking a Senior CQV Engineer to join our team in Australia. The successful candidate will be responsible for developing documentation to support Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
The role involves:
- Developing documentation for 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
Requirements include:
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
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
Familiarity with Baseline Guide 5 (Second Edition) a plus
Other Requirements:
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
In return for your skills and knowledge, CAI offers a wide range of benefits, including:
Highly Competitive Salary
Continuing education (internal and external)
Opportunities to work on cutting-edge projects in a highly evolving field
We are an equal opportunity employer, proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company, and we pledge to operate in a way that is fair and equitable to all – our employees, our customers, and the broader society.
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