3 Days Left: CSV Engineer

Overview

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, that has grown year over year to more than 800 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.

Are You Ready?

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.

Responsibilities

- Develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution.
- Write GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. Other duties may include:
- Prepare/review validation documentation related to projects/change controls.
- Manage change controls and other compliance related tasks e.g., non-conformances.
- Participate in the review of current and future CSV procedures and policies.
- Analyze the results of testing and determine the acceptability of results against predetermined criteria.
- Investigate and troubleshoot problems and determine solutions or recommendations for changes and/or improvements.
- Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
- Coordinate with other departments or outside contractors/vendors to complete validation tasks.
- Participate in regulatory audits and communicate company’s computer validation policies.
- Assess company’s computer systems and identify any potential Part 11 or Annex 11 gaps.
- Manage projects and prepare 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 of experience working in a GMP environment
- Experience in Data Integrity with GAMP and 483, compliance, and deep 21CFR Part 11 experience is highly desired
- Experience in biotech and pharma is preferred over medical device
- Experience with MES, Delta V, PI is a plus; experience with Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and related platforms (PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware) is noted
- 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 and ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
- Independent individual and yet a strong team player

Benefits

- Highly Competitive Salary
- Continuing education (internal and external)
- Opportunities to work on cutting edge projects in a highly evolving field

CAI is an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).

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