Validation Engineer

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

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Associate II, Validation (Science/Tech/Engineering Path), is primarily responsible for handling complex tasks in the Validation discipline, including planning, executing, and documenting validation studies, conducting risk assessments, and preparing reports. You will make significant decisions and support validation activities.

Specifics Include:

• Handle complex tasks and contribute to advanced projects in the Validation discipline
• 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 Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
• Commit to continuous improvement and regulatory compliance, meeting individual job requirements and contributing to overall organizational compliance.

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

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