Validation Engineer

4 days ago

Budapest, Budapest, Hungary EQVAL Full time $60,000 - $90,000 per year
EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.We are seeking a Validation Engineer – Process Development to join our team in a Medical Device Manufacturing environment, supporting initiatives that ensure compliant, reliable, and efficient process development and validation for new and existing products.Requirements:

  • Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, Chemical, or related field)

  • 2+ years of experience in validation engineering or process development within a regulated manufacturing environment (medical device or pharmaceutical preferred)

  • Solid understanding of IQ/OQ/PQ, process validation, and Master Validation Plans

  • Knowledge of GMP, FDA, and ISO 13485 quality system requirements

  • Experience with statistical sampling plans and data analysis for process qualification

  • Strong documentation and technical writing skills (validation protocols, reports, manufacturing instructions)

  • Ability to work cross-functionally with engineering, manufacturing, and quality teams

  • Excellent problem-solving, organizational, and communication skills

  • Fully bilingual (English/Spanish) preferred

Responsibilities

  • Support process and equipment validation activities, including IQ, OQ, and PQ execution and documentation

  • Develop and maintain Master Validation Plans for new products and processes

  • Review, author, and approve validation protocols, reports, and supporting documentation

  • Collaborate with the Process Development team to qualify and implement new manufacturing processes

  • Design and develop in-process and receiving inspection systems to ensure component and process quality

  • Generate equipment documentation, including entries, evaluations, and PM/calibration procedures

  • Define and qualify gages, tools, and test equipment used in process verification

  • Create manufacturing instructions (MIs) and work with cross-functional teams to integrate new processes into production

  • Ensure compliance with the Quality Policy and Quality Management System (QMS)

  • Promote a culture of patient safety, quality, and continuous improvement across all validation activities

Work Details

  • Location: On-site, Dorado, PR (full-time)

  • Schedule: 1st shift

  • On-site role – Applicants must currently reside in Puerto Rico

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