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MODA-ES CSV Support

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Bachelor's degree in relevant field, Minimum 2 years experience in validation deliverables, 2-5 years as a technical writer, Experience with MODA-ES methodologies, Understanding of QC Lab and manufacturing processes.

Key responsabilities:

Design and maintain model-driven architectures
Develop validation scripts for testing applications
Gather and document end-user requirements
Implement and test necessary changes
Prepare and author Knowledge Articles

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

Utilize MODA-ES principles to design, implement, and maintain model-driven architectures for embedded systems.
Develop validation scripts to test Python or similar programming.
Develop Computer System Validation deliverables for FDA-regulated applications for laboratory and manufacturing systems.
The role will include technical administrative support in the MODA-ES application (training will be provided).
This role includes administration, support for end-users, and support for the application development team.
Gather and document end-user requirements.
Implement and test all changes, as required.
Work with the end user for acceptance testing.
Help to move the changes into the appropriate staging area.
Prepare and author Knowledge Articles, as required.

Requirements:

Bachelor's degree in chemistry, engineering, or computer science.
Minimum 2 years of experience in developing Computer System Validation deliverables, with a focus on MODA-ES methodologies and Python, Java or other similar programming languages. (from reading/understanding point of view, not programming).
2 - 5 years of experience as a Good Documentation Practice technical writer.
We are seeking candidates eager to learn new applications.
Strong customer service and teamwork oriented.
Highly flexible, adapting to changes in priorities, requirements, and processes is required.
Excellent communication skills in English, both verbal and written.
Excellent organizational skills and attention to detail and accuracy.
Requirements gathering, testing, and implementation experience.
Great interpersonal skills.
The ability to work independently and with teams.
Ability to work on multiple concurrent project initiatives.
General understanding of QC Lab and manufacturing process/systems is a plus.