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
