Validation Specialist

For Validation services in the Manufacturing area.

FITS is looking for a Validation Specialist to support a leading pharmaceutical manufacturer. You’ll be the hands-on executor of the site’s revalidation program, keeping manufacturing equipment and washers in a qualified state through accurate, well-documented protocol execution. If you’ve spent years in the field running validations and take pride in documentation that is right the first time, this role is for you.

WHAT MAKES YOU A FIT: 

• Bachelor’s degree in Engineering or Science and 5+ years of experience executing validation protocols in a regulated pharmaceutical environment
• Shift: Administrative and according to business needs
• Bilingual (Spanish and English)

Preferred Qualifications:

• Experience executing revalidation/requalification of manufacturing equipment
• Experience executing revalidation of washers

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 

• Execute approved revalidation and requalification protocols for manufacturing equipment and washers according to the site’s revalidation schedule
• Perform protocol activities such as installation and configuration verification, functional and operational testing, alarm and interlock challenges, cycle verification, and performance testing
• Set up, operate, and verify calibration status of validation test equipment and instrumentation before execution
• Collect complete objective evidence and test data that meets Good Documentation Practices (GDP) and ALCOA+ principles
• Document protocol discrepancies and deviations, and support impact assessments, troubleshooting, and retesting
• Prepare execution summaries and revalidation reports that clearly present results, discrepancies, resolutions, and conclusions
• Assemble complete execution packages, including protocols, raw data, attachments, and discrepancy records, for Quality review and approval
• Address review comments and close documentation within the agreed schedule
• Coordinate execution with Manufacturing, Quality Assurance, Maintenance, Metrology, and Engineering to schedule equipment availability and minimize production impact
• Support change control assessments to determine revalidation requirements for equipment modifications
• Work in electronic validation, documentation, and quality systems after access and training are completed.

Being a FITS Piece Comes With Perks

• Work on high-impact projects with one of Puerto Rico’s top pharmaceutical manufacturers
• Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices

Who We Are
FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a lasting match.

Are you the Next Piece?