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.

About fitspr

• 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?

Responsibilities

• 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.
• Bachelor’s degree in Engineering or Science and 5+ years of experience executing validation protocols in a regulated pharmaceutical environment

Administrative and according to business needs

• 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

Preferred

• 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)
• Work in electronic validation, documentation, and quality systems after access and training are completed.