WHO NEEDS A JOB?

We work with the latest technologies and therapies to change lives for the better.  If you have a sharp mind, a willingness to learn, and are dedicated to making the world a better place, we have opportunities for you.

We are seeking a Computer Systems Validation Professional with life sciences experience to manage the delivery of enterprise computer system validation projects. You will be working with a diverse set of validated, GMP computer applications that are server and cloud based. We are searching for creative, critical thinkers that have a deep understanding of how to leverage a risk-based approach for commercial life sciences companies. You will be ensuring that the companies validation policies and procedures are followed to ensure compliant, on-time delivery to GMP systems. This will include taking ownership of validation deliverables and driving the project to successful completion by ensuring daily tasks and project milestones are met. You will report to the Director of the Quality Engineering - Computer System Validation. Your insights and experience will shape the projects' validation strategy and work products. Excellent communication skills and project management skills are required because you will coordinate activity, deliverables and tasks with other company stakeholders, such as IT, logistics, QA, manufacturing, and project management. Some limited protocol preparation and script writing may be required. You will work at the client site, with other stakeholders to mitigate project risks and streamline processes real-time. Full time hours and a minimum of 4 days/week of on-site presence is required.

Qualifications:

- Ability to lead teams and develop strategy based on GMP risk

- Computer science, Engineering or Life Sciences degree is required

- A minimum of 5 years of direct experience in validation within the biopharmaceutical, medical device, nutraceutical and/or food industries

- A minimum of 5 years of CSV experience with enterprise systems 

- 2-3 years of project management experience developing interdependencies, project metrics, milestones and dashboards

- Proficiency with creating validation life cycle documentation, SOP writing, operation manual development, and other technical documents 

- In-depth understanding of SDLC

- Experience with writing and executing validation packages 

- Experience with deviation writing and resolution

- Out-going, client facing, can-do attitude

- Excellent English written and verbal skills

- The ability to work effectively with team members and work under minimal supervision

You must be detail oriented, able to meet strict deadlines, and have the ability to work and have fun within a team environment. You must be eligible to work in the US.  

This is for a 1-year temporary employment position in the greater Los Angeles, CA area with an option to extend. We offer a very competitive pay, health and benefits package that will be commensurate with your experience. 

If you think you have the experience, personality and skill set to become part of our dynamic and growing organization, please send your qualified resumes to: gabe.foong@unbound-consulting.com.