Senior Process Expert: Aseptic Quality & Improvement

Alcon; Fort Worth (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Alcon is seeking a Sr. Process Expert to support the U.S. MTO ASPEX Compounding team in Fort Worth, TX, leading investigations and ensuring compliant documentation for health authorities.

You will drive corrective actions, collaborate with SMEs, and manage change control to optimize product quality, safety, and yield. Responsibilities include conducting deviations investigations, authoring reports per cGxP standards, and delivering continuous improvements across production processes.

Qualifications

• Bachelor's degree or equivalent years of directly related experience.
• Fluent reading, writing, understanding and communicating in English.
• 5 Years of Relevant Experience.
• 3 Years of Demonstrated Leadership.
• Work hours: 40.
• Travel Requirements: No Travel.
• Relocation assistance: Yes.
• Sponsorship available: No.

Responsibilities

• Lead product and process related investigations and implement changes to reduce error reoccurrences.
• Conduct thorough investigations for deviations that occur in the manufacturing and distribution process.
• Create consistent, detailed investigation documentation suitable for use with Health Authorities and Notified Bodies.
• Author investigation reports in accordance with applicable standards (e.g., cGxP, SOPs).
• Communicate status of investigations and escalation issues as appropriate.
• Ensure that all process changes are managed through appropriate change control procedure.
• Lead or support aseptic improvement projects in conjunction with subject matter experts (SME) to ensure product quality and consistent plant operations.
• Execute protocols and continuous improvement support for Production initiatives and prepare documentation related to procedures, training, and work instructions to target productivity improvements (quality, safety, and yield).
• Implement cycle time and cost reduction initiatives.
• Make decisions on resolving major technical problems while minimizing downtime on equipment and processes. Prioritize workload to meet Site and production requirements.
• Identify and implement improvements to controls equipment and processes in support of the ASPEX Site.
• Assist with corrective actions to improve product quality and reduce waste. Participate in Capital Projects, including management of internal/external resources and validations. Provide expert level support and advice to the organization on key processes as well as global support when requested.
• Assist with the development of production personnel on troubleshooting control systems, hardware and provide technical training promoting a team environment and preparing them for higher levels of responsibilities.
• Develop and update SOPs to support process and procedure changes to equipment and standard procedures.

Skills

English proficiency

Leadership

Education

Bachelor's Degree or equivalent experience

Education equivalencies (High school +13 yrs; Assoc.+9 yrs; MS +2 yrs; PhD +1 yr)

Job description

Alcon is seeking a Sr. Process Expert to support the U.S. MTO ASPEX Compounding team in Fort Worth, TX, leading investigations and ensuring compliant documentation for health authorities.

You will drive corrective actions, collaborate with SMEs, and manage change control to optimize product quality, safety, and yield. Responsibilities include conducting deviations investigations, authoring reports per cGxP standards, and delivering continuous improvements across production processes.