Senior Validation Engineer I (Pharmaceutical Manufacturing)

Location: Singapore Manufacturing - Tuas

Company

hirify.global develops biologic medicines and technologies to help patients living with serious illnesses.

What you will do

• Lead technical support for commissioning, qualification, cleaning validation, and validation lifecycle maintenance.
• Establish validation strategies and procedures aligned with operating standards and regulatory expectations.
• Coordinate validation activities with Manufacturing, Engineering, Quality, Supply Chain, and Process Development.
• Prepare, review, and approve validation documentation, including protocols, reports, SOPs, deviations, CAPAs, and change-control assessments.
• Provide subject matter expertise for regulatory filings, audits, inspections, and responses to validation-related questions.
• Maintain the site validation master plan and validated state while leading continuous-improvement initiatives and coaching engineers.

Requirements

• Doctorate degree, or a master’s degree in engineering with 2 years of experience, a bachelor’s degree in engineering with 4 years of experience, or a diploma in engineering with 8 years of experience in a pharmaceutical company or GMP environment.
• Experience with equipment qualification, cleaning validation, commissioning, qualification, and change management.
• Experience executing validation activities for cleaning processes, steaming validation including autoclaves, and controlled temperature chambers.
• Experience maintaining the validated state through continued verification and resolving complex investigations using root cause analysis tools.
• Experience supporting regulatory submissions, inspections, auditor discussions, and observational response plans.
• Strong technical writing, presentation, collaboration, time-management, and multitasking skills, with experience training or coaching junior engineers.

Nice to have

• Extensive experience with equipment qualification and cleaning validation for pharmaceutical facilities.
• Knowledge of small-molecule cleaning and manufacturing unit operations.

Culture & Benefits

• Collaborative environment focused on continuous learning and meaningful work.
• Professional and personal development opportunities.
• Competitive benefits.
• Medical checks required for the role are paid for by the company.
• Inclusive workplace with reasonable accommodations for qualified individuals with disabilities.