CSV Consultant

Creative Solutions Services, LLC; Denver (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a candidate with strong experience in pharmaceutical/biotech/medical device validation. The role emphasizes experience with System Development Life Cycle, Computer System Validation, and adherence to FDA/GxP standards.

The position involves leading validation efforts, coordinating documentation, and collaborating with QA and cross-functional teams. Ideal candidates will have hands-on experience writing validation deliverables, reviewing test scripts,

Qualifications

• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience in writing and executing documentation for validation deliverables (requirements, validation plans, test protocols, test summaries, validation reports).
• Experience in QA methodologies, reviewing and approving test plans, UAT scripts and test procedures.
• Experience with FDA guidance and industry standards (GAMP).

Skills

Regulatory experience

GxP knowledge

Documentation proficiency

QA methodologies

Job description

Roles & Responsibilities:

• Ex-Pharmaceutical preferred.
• Experience in the Pharmaceutical, biotechnology, or medical device industry.
• 2+ years' experience with System Development Lifecyle.
• 3+ years' experience in Computer System Validation (Based on the role selected).
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance's and industry standards (i.e., GAMP).
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
• Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously.