Validation Engineer, Quality & Regulatory Impact

Alcon; Batam; On-site; IDR 120,000,000 - 180,000,000; Full time

Job summary

Alcon is seeking an Associate II, Validation (Science/Tech/Engineering Path) to handle complex tasks including planning, executing, and documenting validation studies, performing risk assessments, and preparing reports. The role requires contributing to aseptic process management, change control, and audit support within a GxP framework.

You will work with cross-functional teams to drive problem-solving and ensure compliance with SOPs and regulatory standards while delivering high-quality

Qualifications

• Associate shall have appropriate education and experience to perform the responsibilities.
• Experience with validation studies and regulatory requirements is preferred.

Responsibilities

• Handle complex tasks and contribute to advanced projects in Validation.
• Plan, execute, and document validation studies to ensure equipment, systems, and processes operate effectively and comply with regulations.
• Conduct risk assessments, design protocols, analyze data, and prepare validation and qualification reports.
• Make significant decisions within your project area, influencing outcomes with enhanced technical skills and problem-solving abilities.
• Support validation activities for aseptic process management.
• Review and approve change control documentation.
• Provide audit support and collaborate with cross-functional teams to drive problem-solving and innovation.
• Adhere to GxP regulations by following SOPs, maintaining accurate documentation, ensuring quality control, and completing required training.
• Commit to continuous improvement and regulatory compliance.

Skills

Validation planning

Risk assessment

Data analysis

Documentation

Cross-functional collaboration

Problem solving

Job description

Alcon is seeking an Associate II, Validation (Science/Tech/Engineering Path) to handle complex tasks including planning, executing, and documenting validation studies, performing risk assessments, and preparing reports. The role requires contributing to aseptic process management, change control, and audit support within a GxP framework.

You will work with cross-functional teams to drive problem-solving and ensure compliance with SOPs and regulatory standards while delivering high-quality