Company: AMP Solutions LLC
Location: Onsite – New York, NY
Job Type: Contract
About AMP Solutions LLC:AMP Solutions LLC is a trusted partner in delivering high-quality engineering, scientific, and compliance solutions to the life sciences industry. We are committed to driving excellence through innovation, collaboration, and integrity. Join our team of dedicated professionals and be a part of shaping the future of healthcare and pharmaceutical compliance.
Position Overview:We are seeking a skilled and detail-oriented Cleaning Validation Engineer to join our team onsite in New York. The ideal candidate will have strong experience in cleaning validation processes within a regulated pharmaceutical or biotechnology environment. You will be responsible for developing, executing, and documenting cleaning validation protocols in compliance with cGMP, FDA, and other regulatory standards.
key Responsibilities:
· Lead the development of cleaning validation documentation, including master plans, protocols, and reports.
· Author and execute cleaning validation protocols (IQ/OQ/PQ) for equipment, CIP/SIP systems, and utilities.
· Conduct risk assessments and gap analyses based on historical data to ensure regulatory compliance (FDA, EMA, WHO).
· Implement cleaning validation strategies, including hold time studies, swab/rinse sampling, recovery studies, and worst-case product matrix identification.
· Perform MACO calculations using PDE, therapeutic dose, and toxicological data.
· Manage the cleaning validation lifecycle, including revalidation criteria and continuous improvement initiatives.
· Collaborate closely with QA, QC, Engineering, and Manufacturing teams to minimize production disruptions.
· Review and approve related SOPs, batch records, protocols, and reports.
· Investigate deviations or failures and write associated CAPAs.
· Liaise effectively with internal stakeholders and assist in project planning and execution.
Required Qualifications:
· Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences).
· 3 to 5 years of experience in cleaning validation within a pharmaceutical or GMP-regulated environment.
· Proficient with ASTM E2500 or verification-based validation approaches.
· Experience with cross-functional collaboration and validation support in large-scale or GMP operational projects.
· Strong communication and organizational skills.
· Proactive, detail-oriented, with a can-do attitude and strong ownership.
· Capable of working independently and escalating issues when needed.
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