Cleaning Validation Engineer I

About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary: 
The Cleaning Validation Engineer I is responsible for supporting the execution and documentation of cleaning validation activities in accordance with cGMP, internal SOPs, and applicable regulatory requirements. This role provides hands-on support for protocol preparation, execution, data collection, and reporting, while ensuring adherence to established validation standards and data integrity principles. Under general supervision, the incumbent supports the maintenance of the validated state of equipment and processes and gains practical exposure to regulatory expectations in a fast-paced pharmaceutical manufacturing environment.

Key Responsibilities:

• Assist in drafting and executing cleaning validation protocols, sampling plans, test scripts, and final reports.
• Collect and analyze data from swab and rinse sampling, recovery studies, and laboratory results.
• Document results in compliance with ALCOA data integrity principles.
• Perform all work in accordance with cGMP, SOPs, company policies, and safety requirements.
• Maintain accurate validation records and support change controls, deviations, and CAPAs as assigned.
• Support internal and external audits and inspections by providing documentation and technical input.
• Assist in monitoring validated cleaning processes to ensure continued state of control.
• Support equipment and process assessments for cleaning validation applicability and risk.
• Coordinate with Manufacturing, Quality Control, Engineering, and Quality Assurance on sampling and execution activities.
• Escalate risks, delays, or technical issues to supervisors in a timely manner.
• Support investigations of cleaning-related deviations or failures under senior engineer guidance.
• Apply basic knowledge of PDE/MACO calculations, risk assessments, and regulatory expectations for cleaning validation.
• Knowledge of swab and rinse sampling techniques, recovery concepts, and contamination control practices for cleaning validation.
• Participate in training programs related to cleaning validation, statistics, and regulatory guidance.

Education

• Bachelor’s degree in Science, Engineering, or a related technical discipline.

Knowledge, Skills and Abilities

• Knowledge of pharmaceutical cleaning processes, cGMP, and regulatory requirements (FDA, EMA, Health Canada).
• Strong attention to detail and documentation accuracy.
• Ability to work independently with supervision and within cross-functional teams.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Excel and Word; familiarity with LIMS, TrackWise, or similar systems is an asset.

Experience:

• Minimum 0 – 2 years of experience in a pharmaceutical, biotechnology, or similarly regulated environment (internship or co-op experience may be considered).
• Prior exposure to validation, quality assurance, or laboratory environments preferred.

Benefits:

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan

• Medical/Dental/Vision Insurance
• Paid Time Off
• 401k with employer match
• Paid Holidays and Floating Holiday

Equal Opportunity Employer

Salary : $80,000 - $90,000