Senior Validation Engineer

Role Overview

Specifics Include

• Handle technical tasks, supporting operations and contributing to efficiency within defined procedures.
• 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.
• Support validation activities in aseptic process management.
• Review and approve change control documentation.
• Provide audit support and collaborate with cross-functional teams to drive problem-solving and innovation through scientific principles.
• Make decisions within the scope of assigned tasks, requiring advanced technical knowledge and analytical skills.
• Perform assigned validation activities on time.
• Handle deviations associated with these activities, if required.
• Author complex validation protocols and technical reports (e.g. launches, transfers, weak point remediation).
• Perform process qualification for new equipment and new technologies.
• Participate in transfers and launches by providing data obtained during related validation activities which are needed for the registration documentation.

What You'll Bring to Alcon

• Bachelor's Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 2 Years of Relevant Experience
• Work hours: Exempt
• Travel Requirements: None
• Relocation assistance: No
• Sponsorship available: No

Preferred Qualifications/Skills/Experience

• Experience working in a regulated pharmaceutical, biologics, medical device, or aseptic manufacturing environment.
• Experience with change control, deviation investigations, CAPA, and quality management systems.
• Proficiency in data analysis, statistical methods, and trending of validation data.
• Experience using statistical analysis software such as Minitab.
• Experience with temperature mapping, thermocouple data loggers, and thermal validation studies.
• Experience with sterilization validation, including E-Beam, EO, steam, or other sterilization technologies.
• Demonstrated project management, organizational, and cross-functional collaboration skills.
• Ability to independently manage multiple validation projects and meet established timelines.

How You Can Thrive at Alcon

• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

Additional Information