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.
...to detail and ability to work independently or as part of a team. Excellent time management skills with the ability to prioritize tasks effectively. MUST HAVE A MINIMUM Of (2) YEARS OFFLOORCLEANING EXPERIENCE. NOTE: From Time To Time, You May Be Asked To...
...Head of Petroleum Engineering About the Company Innovative alternatives firm Industry Financial Services Type Privately Held About the Role The Company is seeking a Head of Petroleum Engineering to join their dynamic team. The successful candidate...
...in the industry, with first-year earnings ranging from $150,000 to $250,000or more! Fast Start Program: We're offering a $3k Sign on Bonus as well as a training program designed to put cash in your pocket immediately as you begin your journey with us!...
...at ERS and see why we were named a Top Workplace in 2024 by the Austin American-Statesman. Learn about us here!ERS is seeking a RPA Developer to perform highly complex to highly advanced (senior-level) designing, developing, and implementing Robotic Process Automation (...
Traveling CarpenterWorking closely with the Carpenter Supervisor, you will build, repair, and maintain woodwork, doors, locks, wallpapering, wall paneling, carpeting, and other related elements. You will also be responsible for sealing off critical working areas from...