Senior Engineer (Validation)

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon and we are looking for a Senior Engineer (Validation) in Fort Worth, TX. The Senior Engineer (Validation) role is critical to ensuring the successful development of innovative products. This position is responsible for key validation activities, including non-conformance investigations, aseptic process qualification, equipment and cleaning validation, and risk management. By ensuring compliance with regulatory standards and driving continuous process improvements, the Senior Engineer (Validation) will support the efficient and compliant development of both pilot and clinical-stage products, directly contributing to the company’s product quality and regulatory success.

In this role, a typical day will include:

Critical Utilities Validation

• Lead the validation of critical manufacturing systems, including HVAC, water, steam, compressed air, and other utility systems.

• Apply in-depth knowledge of critical utilities and their validation processes.

• Maintenance of key utility systems such as HVAC, water, steam, and compressed air.

• Ensure compliance with regulatory requirements (FDA, GMP, ISO) for utility systems, meeting both internal and external standards.

Equipment (Lab and Pilot Equipments) and Process Validation (Cleaning & Aseptic Process):

• Collaborate with the Pilot Line SMEs, ensuring proper maintenance, troubleshooting, thorough and regular inspection of all equipment and utilities as well as production support equipment and continuous improvement.

• Participate in the validation and requalification of lab and pilot equipment, ensuring that systems meet performance specifications and are fully operational to support R&D and manufacturing processes.

• Develop and execute cleaning validation protocols for equipment and facilities to ensure compliance with regulatory requirements and are effective in maintaining a contamination-free environment.

• Participate in Pilot Production and Aseptic Processing activities.

Risk Assessment and Non-Conformance Investigation:

• Conduct risk assessments for aseptic processes, pilot production, and equipment, implementing mitigation strategies as needed.

• Lead non-conformance investigations, perform root cause analysis, and implement corrective and preventive actions (CAPA) in line with regulatory and GMP standards.

Operational Systems Improvement and Quality Compliance:

• Collaborate with the Pilot Operation Team to enhance operational efficiency, simplify processes, and ensure audit readiness and compliance.

• Partner with the Quality team to ensure all activities comply with GMP, SOPs, and regulatory requirements, driving system improvements and continuous quality assurance.

• Provide technical support during audits, investigations, and regulatory inspections, offering clear documentation and evidence of validation activities and results.

Experience:

• A Bachelor's or Master's degree in Pharmaceutical Sciences, Engineering, Life Sciences, Biotechnology, or a related field.

• Minimum of 5-7 years of experience in validation, with at least 3 years focused on critical utilities in regulated environments (e.g., pharmaceutical, biotech, medical device).

• Technical expertise in manufacturing utilities and equipment.

• In-depth knowledge of Good Manufacturing Practices (GMP), aseptic techniques, process validation, and risk management.

• Comprehensive experience with regulatory standards, including FDA, EMA, and other industry-specific guidelines.

• Ability to quickly adapt to changes, demonstrating resilience and maintaining a positive attitude while staying focused on achieving results.

• Ability to work independently and as part of a team, with a focus on collaborating effectively across departments to drive improvements and ensure compliance.

• Strong organizational skills with the ability to manage multiple projects concurrently, ensuring all tasks are completed on time and in compliance with regulation.

• Ensures all work conforms to current Good MFG Practices (GMP) and meets all Standard Operating Procedures (SOPs).