Senior Validation Engineer

Alcon•Fort Worth, TX

19h

About The Position

The Senior Validation Engineer, described in the posting as a Sr. Associate, Validation (Science/Tech/Engineering Path), supports and completes validation and qualification activities for processes, equipment, systems, and facilities. The role prepares, reviews, and rectifies validation protocols; provides technical support; and helps manage department expenses. It performs validation work within defined procedures and applies advanced technical knowledge and analytical skills to assigned tasks. The position plans, executes, and documents validation studies to confirm that equipment, systems, and processes operate effectively and comply with regulations. It supports aseptic process management, audits, transfers, launches, product improvement, and remediation. The role also authors complex protocols and technical reports, performs process qualification for new equipment and technologies, and provides validation oversight for change control documentation. The engineer is expected to follow GxP regulations and SOPs, maintain complete and accurate records, complete required training, and contribute to quality, compliance, and continuous improvement. The position is exempt, requires no travel, and does not offer relocation assistance or sponsorship. It may be offered at Associate I or Associate II Engineering level depending on the candidate’s qualifications and experience.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatives listed are high school plus 10 years, associate degree plus 6 years, or a master’s degree plus 0 years.
Two years of relevant experience.
Ability to fluently read, write, understand, and communicate in English.
Advanced technical knowledge and analytical skills for decisions within the scope of assigned tasks.

Nice To Haves

Experience 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 validation data.
Experience with 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

Plan, execute, and document validation studies for equipment, systems, and processes.
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, including providing validation oversight review and approval.
Provide audit support and collaborate with cross-functional teams on problem-solving and innovation.
Complete assigned validation activities on time and handle related deviations when required.
Author complex validation protocols and technical reports, including those for launches, transfers, and weak point remediation.
Perform process qualification for new equipment and technologies.
Participate in transfers and launches by providing validation data needed for registration documentation.
Perform or oversee risk assessments for Validation.
Participate in product improvement and remediation.
Update documents as needed.
Follow GxP regulations and SOPs, maintain accurate and complete documentation, complete required training, and meet individual job requirements.
Support operations and contribute to efficiency within defined procedures.
Help manage department expenses.