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 including URS, FAT, SAT, CSV.
• Proven track record in supporting full project implementation from design to qualification.
• Strong experience in executing capital projects in GMP-regulated environments.
• Familiarity with GMP, ISO standards, Lean Manufacturing, and FDA regulations.
• Ability to work independently and lead solutions under general guidance.
• Strong organizational and communication skills.

Responsibilities

• Develop User Requirement Specifications (URS).
• Lead full validation lifecycle activities, including FAT, SAT, CSV, and equipment integration.
• Drive process design for new equipment ensuring design requirements are met.
• Execute commissioning and qualification activities for new and existing equipment.
• Provide technical oversight to ensure compliance with safety and regulatory standards.
• Manage suppliers and external vendors on capital projects, controlling scope and costs.
• Collaborate with Procurement and Legal on vendor contracts.
• Create and maintain engineering documentation including URS and assembly instructions.
• Optimize equipment design for manufacturability and operational efficiency.
• Lead design reviews, risk assessments, and FMEA for equipment reliability.
• Ensure compliance with safety regulations and quality policies including GMP standards.
• Apply statistical analysis to support decision-making and manage multiple priorities.

Benefits

• Opportunity to work in a dynamic team environment.
• Exposure to capital project management and vendor relations.
• Hands-on experience in cutting-edge equipment design and qualification.
• Opportunity to contribute significantly to product safety and compliance standards.