CSV Engineer
Melbourne / Australia / Full Time
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to over 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. 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, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include:
Position Description:
We are now seeking CSV Engineers to join our growing operations in Australia. The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. Other duties may include:
• Prepares/reviews validation documentation related to projects/change controls.
• Manages change controls and other compliance related tasks e.g., non-conformances.
• Participates in the review of current and future CSV procedures and polices
• Analyses the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates company’s computer validation policies.
• Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
• Manages projects and prepares status reports using Microsoft project and other communication tools.
• May supervise, lead, or manage lower-level personnel.
Position Requirements:
BS in a Computer Science or Engineering field or equivalent experience
Minimum 2-7 years’ experience with Computer systems validation.
Minimum 2-7 years' experience working in a GMP environment.
Experience in Data Integrity with GAMP and 483, compliance, deep 21CFR Part 11 experience highly desired
Experience in biotech and pharma is preferred over medical device.
Experience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required.
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.
Independent individual and yet a strong team player.
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.
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