Bachelor's degree in Engineering or Science required.
At least 4 years of experience in pharmaceutical or medical device sectors.
Proven expertise in the full validation lifecycle including URS, FAT, SAT, and CSV.
Experience in supporting complete project implementation from design to qualification.
Strong background in executing capital projects in GMP-regulated environments.
Familiarity with GMP, ISO standards, Lean Manufacturing, and FDA regulations.
Excellent organizational and communication skills; ability to work autonomously.
Responsibilities
Develop User Requirement Specifications (URS).
Lead comprehensive validation lifecycle activities including FAT, SAT, and CSV.
Drive the design process ensuring equipment meets product requirements.
Execute commissioning and qualification for both new and existing equipment.
Provide technical oversight for safety, regulatory, and operational compliance.
Manage suppliers and ensure effective vendor collaboration on capital projects.
Create and maintain essential engineering documentation for projects.
Benefits
Collaborative work environment with cross-functional teams.
Opportunities for professional growth and continued education.
Engagement in diverse and impactful projects in the pharmaceutical/medical device industry.
Chance to contribute to product safety and efficacy in a highly regulated field.
Full Job Description
Validation Engineer
Description:
The role demands deep technical expertise across the full validation lifecycle - including URS development, FAT/SAT execution, and Computer System Validation (CSV) - as well as hands-on experience with systems and controls integration. The candidate will drive end-to-end project implementation: from equipment design and installation through startup, commissioning, and qualification.
Key Responsibilities:
Develop User Requirement Specifications (URS).
Lead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.
Drive process design for new equipment and ensure product design requirements are met.
Execute commissioning and qualification activities for new and existing equipment.
Provide technical oversight to ensure equipment meets safety, regulatory, and operational standards.
Manage suppliers and external vendors on capital projects, controlling scope, cost, and lead time.
Collaborate with Procurement and Legal on vendor contracts.
Create and maintain engineering documentation (URS, assembly instructions, bill of process, etc.).
Optimize equipment design for manufacturability, cost reduction, maintainability, and efficiency.
Lead design reviews, risk assessments, and FMEA to ensure reliability and performance.
Ensure compliance with all safety regulations and quality policies, procedures, and GMP standards.
Apply statistical analysis and SPC systems to support data-driven decision-making.
Manage multiple priorities and maintain equipment qualification schedules.
Qualifications:
Bachelor's degree in Engineering or Science.
Minimum 4 years of engineering experience in pharmaceutical and/or medical device industries.
Demonstrated experience across the full validation lifecycle (URS, FAT, SAT, CSV).
Proven track record supporting full project implementation: design, installation, startup, commissioning, and qualification.
Strong experience executing capital projects within GMP-regulated manufacturing environments.
Familiarity with GMP, ISO standards, Lean Manufacturing, and FDA-regulated environments.
Ability to work independently and lead solutions under general direction.
