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.
Strong organization and communication skills.
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.
Benefits
Opportunity to work on impactful projects in the pharmaceutical and medical device sectors.
Engagement in the full validation lifecycle, enhancing technical expertise.
Collaboration with cross-functional teams, including Procurement and Legal.
Exposure to capital project management and vendor relations.
Focus on compliance with safety and quality standards, ensuring a robust work environment.
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.
Strong organization, and communication skills
Excited to build something meaningful together? We look forward to hearing from you.
