ABOUT THE POSITION

Aurion Biotech is a clinical-stage biotechnology company dedicated to restoring vision to millions of patients through innovative regenerative therapies. Our lead candidate is an allogeneic cell therapy designed to treat corneal edema secondary to corneal endothelial disease. Our cell therapy is PMDA approved, and commercialization started in Japan in 2024. In the US, the program has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the FDA and it is advancing into Phase 3 clinical trials in 2025. Aurion operates as a separate entity with full support from Alcon.
Aurion Biotech is seeking a motivated Process Engineer reporting into the Manufacturing Validations Lead Engineer. This role will support validation and comparability efforts for innovative cell therapy manufacturing processes as we progress through late-stage clinical development and prepare for commercial readiness. The ideal candidate has foundational experience in GMP environments through internships, co-op programs, or early career roles and is excited to build expertise in validation protocols, comparability assessments, data analysis, and regulatory documentation.
This role is an excellent opportunity to grow within a mission-driven biotech company focused on regenerative therapies for ocular diseases. You will work closely with cross-functional teams and CDMOs, contributing to BLA-enabling activities and helping to ensure the robustness and compliance of our manufacturing processes.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• B.S. in Chemical Engineering, Bioengineering, Biological Sciences, or a related discipline.
• 0–2 years of experience in GMP manufacturing, MSAT, or process validation (internship or co-op experience acceptable).
• Familiarity with cGMP regulations and principles of validation and comparability for biologics or cell therapy.
• Some experience in drafting or reviewing technical documents such as protocols, reports, or batch records is preferred.
• Understanding of statistical analysis tools (e.g., Excel, JMP, Minitab) is preferred.

REQUIRED SKILLS AND ABILITIES

• Strong attention to detail and technical writing skills.
• Ability to interpret data and apply engineering or scientific principles to solve problems.
• Excellent communication and collaboration skills across cross-functional teams.
• Organized and proactive with a willingness to learn and contribute in a fast-paced environment.
• Proficient in MS Office (Excel, Word, PowerPoint); exposure to JMP or similar tools is a plus.
• Ability to travel up to 25%

KEY RESPONSIBILITIES

• Support the authoring and review of validation and comparability protocols, reports, and risk assessments for process validation (e.g., PPQ) and ancillary validation activities under the guidance of the Manufacturing Validations Lead Engineer
• Gain GMP knowledge by owning qualifications and Person-in-Plant activities at CMOs
• Assist in preparing data packages for regulatory filings, inspections, and information requests.
• Compile data, perform preliminary analysis, and data verification to support process validation and comparability strategy.
• Contribute to the organization and execution of validation activities at CDMOs, including coordination of sampling, materials, and timelines.
• Assist in authoring and maintaining the Process Validation Master Plan and supporting documentation such as range justification reports, process control strategies, equipment qualification summaries, and validation tracking logs.
• Collaborate with Manufacturing, MSAT, Quality, Process Sciences, Process Development and Analytical teams to gather input for validation and comparability documents and deviation/exception assessments.
• Help ensure that validation and comparability activities are conducted in compliance with cGMP, FDA/ICH guidelines, and internal SOPs.
• Participate in process risk assessments (e.g., FMEA) and support data collection for comparability evaluations.
• Maintain validation documentation in electronic systems and ensure accuracy and traceability of all executed records.
• Perform other duties and project-based support as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• B.S. in Chemical Engineering, Bioengineering, Biological Sciences, or a related discipline.
• 0–2 years of experience in GMP manufacturing, MSAT, or process validation (internship or co-op experience acceptable).
• Familiarity with cGMP regulations and principles of validation and comparability for biologics or cell therapy.
• Some experience in drafting or reviewing technical documents such as protocols, reports, or batch records is preferred.
• Understanding of statistical analysis tools (e.g., Excel, JMP, Minitab) is preferred