Employer Industry: Business and IT Services

Why consider this job opportunity:
- Compensation at $50/hr with a contract length of 4 months and a strong likelihood of extension for an additional 12 months
- Opportunity to work remotely from Puerto Rico
- Engage in impactful projects related to software validation in the FDA regulated industry
- Collaborative work environment with a focus on sharing ideas and solutions
- Chance to develop expertise in various validation models and systems
- Work within a leading organization providing services to over 1,000 clients

What to Expect (Job Responsibilities):
- Lead computer system validation projects, including authoring and executing specifications and validation documentation
- Author validation protocols ensuring compliance with relevant regulations and corporate policies
- Review and execute Computer System Validation protocols to ensure adherence to guidelines
- Write risk assessments and prepare validation summary reports for executed protocols
- Assist in resolving deviations and conducting CAPA investigations

What is Required (Qualifications):
- Minimum of 7 years in the FDA regulated industry, with 5+ years of document authoring and SOP revisioning experience
- Working knowledge of GMP, 21 CFR Part 11, and Annex 11
- Experience with Laboratory and Manufacturing Instrument Software Validation
- Familiarity with validating enterprise systems including SAP, Empower, and Veeva
- Excellent written and verbal communication skills

How to Stand Out (Preferred Qualifications):
- Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Information Technology)
- Experience with various validation models, including V-Model and CSA
- Highly motivated with a strong customer service style
- Ability to adapt to change and take initiative
- Proven collaboration skills within team environments

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