Validation Engineer

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

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.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.