Flexible & Integrated Technical Services, LLC
Validation Specialist
Medical Device - Dorado, PR, Puerto Rico - Contracted
For Validation services
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor's in Life Sciences with five (5) years of experience in Validation activities within the Medial Devices Industry.
- Bilingual: English and Spanish
- Soft Skills: Great attitude and strong desire to learn new skills.
- Shift: Administrative, and according to business needs.
- Experience in:
- Validation (OQ/PQ/TMV/IPM)
- Quality Engineering or Manufacturing Engineering
- Validation lifecycle and documentation
- Regulated environments (FDA, ISO, GMP)
- Data analysis tools
- Document management systems
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Utilize automated tools to extract and filter validation documentation (e.g., Windchill → Excel trackers)
- Review and validate extracted data to ensure accuracy, completeness, and site alignment
- Execute detailed assessments across: OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation) and IPM (In-Process Monitoring).
- Apply technical judgment to: Confirm applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.
- Ensure alignment with: Current procedures, global validation standards and Remediation expectations and timelines.
- Validate that extracted data accurately reflects site practices and documentation
- Cross-check validation records against MVPs (Master Validation Plans), PRAs (Product Risk Assessments) and Supporting validation documentation.
- Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM.
- Highlight high-risk, complex, or ambiguous scenarios requiring deeper analysis.
- Proactively identify: Data gaps, Inconsistencies and tool limitations.
- Escalate risks, uncertainties, or blockers to the core team in a timely manner.
- Provide clear documentation of findings and recommended actions.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
.png){kind=small}
