Why join Ajinomoto Bio-Pharma?
Our mission is to help improve the health of humankind.
We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.
We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.
Total Rewards package designed to make your life better:
We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!
Your next career move:
We are currently seeking a Cleaning Validation Engineer III who plays a critical role in ensuring that cleaning validation activities within commercial and clinical fill and finish facilities are compliant with both internal and regulatory standards. This position is responsible for minimizing product cross-contamination risks through the development, validation, and continuous improvement of cleaning processes and procedures. Acting as the Subject Matter Expert (SME) for cleaning verification and validation, the Cleaning Validation Engineer III works across the site to manage all aspects of cleaning procedures for direct, indirect, and non-product contact surfaces in the manufacturing environment.
Responsibilities:
- Leads and executes cleaning validation studies, ensuring all activities are in compliance with FDA, EMA, and other relevant regulatory standards. Develops, authors, and implements cleaning validation protocols for pharmaceutical manufacturing environments and associated equipment.
- Performs comprehensive risk assessments related to cross-contamination and GMP risks. Regularly evaluates and updates cleaning processes to ensure they are appropriate for the level of potential contamination, minimizing the risk of product cross-contamination in a multi-product facility.
- Prepares, executes, and reports on cleaning validation testing across various phases of commissioning and qualification. Maintains thorough documentation in accordance with internal standards and regulatory expectations.
- Assesses the adequacy of existing cleaning methods, ensuring they are suitable for intended use, especially with respect to contamination levels. Develops product-specific cleaning procedures using appropriate cleaning agents and performs GAP assessments to evaluate the effectiveness of cross-contamination controls.
- Analyzes cleaning validation data, including rinse and swab results, and identifies corrective actions where necessary. Troubleshoots and resolves any issues in cleaning validation processes to maintain compliance and operational efficiency.
- Works closely with teams across manufacturing, quality assurance, quality control, and engineering to define cleaning validation requirements and ensure adherence to project timelines. Leads efforts to optimize cleaning cycles, including CIP (Clean-in-Place) and COP (Clean-out-of-Place) systems.
- Ensures compliance with site EHS policies, cGMP regulations, and the company's Quality Management System (QMS). Tracks the validation lifecycle, ensuring documentation and practices are always audit-ready.
- Organizes, schedules, and tracks validation projects, ensuring timelines are met and deliverables are in accordance with client and regulatory requirements. Manages deviations, protocol discrepancies, and associated risk analyses.
Requirements:
- Bachelors degree in Engineering, Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field, required
- Minimum of 5 years of experience in cleaning validation in the pharmaceutical and biotechnology industries.
- Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
- Experience in cleaning validation within the pharmaceutical or biotech industry.
- Knowledge of regulatory requirements such as FDA, cGMP, and industry guidelines related to cleaning validation.
- A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.
- Strong understanding of validation principles and practices for cleaning processes and equipment.
- Excellent communication and collaboration skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Proven experience with Cat 1-4 materials and ADE values preferred
The anticipated salary range for candidates who will work in California is $103,700 - $136,000
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
New hires will be asked to complete a background check and drug screen as a condition of employment.
For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO
We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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