Senior Validation Engineer – Quality & Regulatory

Alcon; Batam; On-site; IDR 180,000,000 - 280,000,000; Full time

Job summary

Alcon seeks a Validation professional to support the Quality & Regulatory Affairs function in Batam. You will plan, execute, and document validation studies ensuring equipment, systems, and processes meet regulatory standards.

Responsibilities include risk assessments, protocol design, data analysis, and submission of validation reports, along with change controls, audits, and cross-functional collaboration to uphold quality and compliance.

Qualifications

• Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.

Responsibilities

• 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.
• 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 documentation, ensuring quality control, and completing required training.

Skills

Risk assessments

Documentation

Validation planning

Regulatory compliance

SOP adherence

Job description

Alcon seeks a Validation professional to support the Quality & Regulatory Affairs function in Batam. You will plan, execute, and document validation studies ensuring equipment, systems, and processes meet regulatory standards.

Responsibilities include risk assessments, protocol design, data analysis, and submission of validation reports, along with change controls, audits, and cross-functional collaboration to uphold quality and compliance.