Senior Validation Engineer

Alcon•Fort Worth, TX

5d•Onsite

About The Position

This role is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes. The Sr. Associate, Validation (Science/Tech/Engineering Path) is primarily responsible for supporting and completing validation and qualification activities for processes, equipment, systems, and facilities. You will prepare, review, and rectify validation protocols, provide technical support, and help manage department expenses.

Requirements

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

Nice To Haves

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.

Responsibilities

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.
Perform or oversee risk assessments for Validation.
Participate in improvement and remediation of products.
Update documents on an as needed basis.
Provide Validation oversight review and approval of change control documentation.
Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation.
Ensure rigorous quality control, complete all required training, and meet individual job requirements to contribute to overall organizational compliance.
Commit to continuous improvement and compliance with regulatory requirements.