Validation & Engineering Group, Inc. · 1 month ago
MF01-112425 PD Validation Engineer (Medical Devices)
Dorado, 051
Full-time
Onsite
Mid Level
3+ years expValidation & Engineering Group, Inc. is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a Validation Engineer to develop and review documentation and procedures, and provide automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.
BiotechnologyConsultingProfessional ServicesQuality Assurance
Responsibilities
Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products
Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures
Design and develop in-process and receiving quality systems for new processes and components
Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required
Define gages, tools and equipment for the test methods developed
Generate manufacturing instructions for new processes being developed
Work cross-functionally with other departments to accomplish PD tasks
Qualification
Required
Bachelor's Degree in Science or Engineering
Minimum of 3 - 5 years of experience in direct pharmaceutical, medical device or biotechnology industries
Experience in medical devices operations
Must be fully bilingual (English / Spanish) with excellent oral skills
Must be proficient using MS Windows and Microsoft Office applications
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance
Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation
SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT)
Strong knowledge (according to related area)
Technical Writing skills and investigations processes
Available to work extended hours, possibility of weekends and holidays
Company
Validation & Engineering Group, Inc.
Validation & Engineering Group, Proudly serving our clients since 1997.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Luis Puig
Partner
Recent News
News is my Business
2025-08-20
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