Validation Specialist - Laboratory Equipment

For Process Validation services in the manufacturing area.  WHAT MAKES YOU A FIT :   The Technical Part : Bachelor's in Life Science or Engineering with five (5) years of experience in Process Validation activities within the Pharmaceutical Industry.

Excellent written and verbal skills in both English and Spanish.

Shift : Administrative and according to business needs.  Experience in : Validation protocol execution and generation for laboratory equipment :   Autoclave,  Glasswasher, Reactor, and  CIP / SIP 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 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 Be The Piece?   AS A PIECE OF FITS, YOU WILL : (The day-to-day on the job) Generate technical justifications for laboratory equipment process changes by conducting risk assessments, impact analyses, and regulatory compliance reviews (FDA 21 CFR Part 11, ICH Q2(R1), USP

) to support modifications in equipment operations, calibration procedures, or analytical methods with comprehensive documentation ensuring traceability and inspection readiness.

Design and develop validation protocols (IQ / OQ / PQ) for laboratory equipment including analytical balances, HPLC / GC systems, spectrophotometers, and pH meters with scientifically justified acceptance criteria based on manufacturer specifications, compendial requirements, and statistical process capability requirements (Cp / Cpk ≥ 1.33, R² ≥ 0.998).

Provide hands-on technical support during validation execution at the laboratory bench by troubleshooting equipment issues in real-time, monitoring environmental conditions, ensuring protocol adherence, conducting root cause analysis for deviations using structured methodologies (5-Why, Fishbone diagrams), and making technical decisions on unexpected results.

Maintain comprehensive documentation including Master Equipment Files, Standard Operating Procedures, calibration certificates, validation reports, and training records ensuring compliance with ALCOA+ data integrity principles and implementing change control processes with impact assessments and revalidation trigger evaluations.

Gather and analyze equipment performance data using statistical process control methods (X-bar charts, CUSUM charts, Gage R&R studies) to monitor Key Performance Indicators such as equipment availability (≥95%), system suitability pass rates (≥95%), calibration compliance (100%), and calculate process capability indices to proactively identify equipment requiring optimization or replacement.

Generate validation and performance reports documenting qualification activities, statistical analyses, deviation resolutions, and equipment health metrics including quarterly performance summaries and annual reviews with recommendations for continuous improvement, lifecycle management, and regulatory compliance demonstration.

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?

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