Validation Engineer (GxP & Compliance)

Alcon MX; Batam; On-site; IDR 180,000,000 - 240,000,000; Full time

Job summary

Alcon seeks an Associate II in Validation to handle complex tasks in validation projects, planning, executing, and documenting studies to ensure equipment, systems, and processes comply with global and local regulations. You will conduct risk assessments, design protocols, analyze data and prepare validation and qualification reports, supporting aseptic process management and change control activities.

You will provide audit support and collaborate with cross-functional teams to drive

Qualifications

• Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role.
• GxP regulations must be adhered to by following SOPs, accurate documentation and training requirements.
• Experience in validation and regulatory compliance within life sciences is preferred.

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 reports.
• 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, and completing required training.
• Commit to continuous improvement and regulatory compliance across projects.

Skills

Plan validation studies

Execute validation studies

Document validation reports

Risk assessment

Aseptic process knowledge

Change control review

Audit support

GxP compliance

Job description

Alcon seeks an Associate II in Validation to handle complex tasks in validation projects, planning, executing, and documenting studies to ensure equipment, systems, and processes comply with global and local regulations. You will conduct risk assessments, design protocols, analyze data and prepare validation and qualification reports, supporting aseptic process management and change control activities.

You will provide audit support and collaborate with cross-functional teams to drive