Senior Validation Engineer — Pharma Systems & Compliance

ProQuality Network

Vega Baja (PR)

On-site

USD 80,000 - 120,000

Full time

10 days ago

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Job summary

ProQuality Network is seeking a Validation Engineer to lead commissioning, qualification, and validation activities across facilities and equipment in North of Puerto Rico. The role involves planning, coordinating, and delivering validation milestones within scope, timeline, and budget while maintaining compliance with CFR, ICH, ISPE, and GAMP5 guidelines.

The candidate will develop and execute validation lifecycle documents, lead protocol execution, data collection and analysis, and support

Qualifications

Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or related field.
7–10 years’ experience for Senior role; 3–5 years for Engineer II; 0–3 years for Engineer I.
Experience in pharmaceutical or regulated manufacturing environment; OSD experience preferred.

Responsibilities

Lead commissioning, qualification and validation activities for facilities, utilities, equipment, process systems and computerized systems.
Develop, review and execute validation documentation (VMPs, URS, FDS, risk assessments, IQ/OQ/PQ, protocols, reports).
Direct protocol execution: data collection, sampling, data analysis, deviations, CAPAs.
Monitor project status and communicate risks/deliverables to teams/leaders.
Maintain compliance with CFR, ICH, ISPE, GAMP5 and data integrity requirements.