Contract Pharmaceutical Validation Engineers

Location: Lawrence
Posted on: June 23, 2025

Job Description:

Our client – a growing company with multiple plants in the US, needs a 2 Pharmaceutical Validation Engineers on a contract basis for cleaning, process, equipment, Utility system projects at their plant. Excellent hourly Pay rate. Citizens and green card holders only. Job Posting 2688 Job Title: Contract Pharmaceutical Validation Engineers Location: Lawrence, KS Qty: 2 needed Comp: Total pay rate of $60 - $70 per hour (Paid weekly) inclusive of personal expenses for living/travel Relocation:Prefer local or someone who can travel and live on their own expenses. Duration: Initial assignment for 6 months, which could be extended based on performance and client needs Visa Status: Only looking for citizens and green card holders Our client is a privately held company with manufacturing sites in CA KS with around 300 people Group Info: Be part of the medical device and pharmaceutical contract manufacturing site with around 120 employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing. This Quality group has around 25 people from Quality Control, Quality Assurance, Compliance. This is a senior individual contributing role and will be responsible for Validation of Equipment, Process, Cleaning and Utilities systems for Sterile Aseptic Liquid Filling and Sterilizer Operations in the Pharma Industry. Job Summary: The Contract Validation Engineer coordinates and assists with all process and equipment changes and implementation of new systems, equipment, and product transfers. Job Description: Technical Transfer Support: Facilitate the transfer of new and existing equipment into production environments, ensuring all validation activities meet regulatory requirements. Validation Planning: Develop comprehensive validation plans and protocols for equipment, processes, and cleaning procedures, adhering to FDA guidelines and industry best practices. Execution and Documentation: Execute validation studies, collect data, and prepare thorough reports documenting validation activities and results. Risk Assessment: Conduct risk assessments related to validation activities, identifying critical parameters and potential hazards to product quality. Cross-functional Collaboration: Collaborate closely with cross-functional teams including Quality Assurance, Manufacturing, and Engineering to ensure alignment and successful validation outcomes. KEY RESPONSIBILITES Equipment & Facility Qualification Lead/execute Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ) Terminal sterilization systems (e.g., autoclaves, dry heat sterilizers) Blow-Fill-Seal (BFS)/Blow-Fill-Cap (BFC) production lines Production Equipment and support system (Formulation Vessels, Pumping systems, CIP. Secondary packaging equipment (e.g., labeling, cartoning, Vision systems) HVAC, cleanroom, and utility systems (e.g., WFI, compressed air, RO systems) Process Validation Support process validation lifecycle activities for transferred or new manufacturing processes associated with sterile or non-sterile production. Ensure critical process parameters are identified, justified, and verified through validation and risk-based approaches. Cleaning Validation Author and execute cleaning validation protocols for product contact equipment ensuring acceptable levels of carryover and residue limits. Support lifecycle management of cleaning procedures, visual inspection criteria, and equipment hold times. Documentation & Compliance Draft and review validation protocols, summary reports, risk assessments, SOPs, and deviations. Ensure alignment with FDA 21 CFR Part 210/211, 21 CFR Part 11, EU Annex 15, ICH Q8–Q10, and internal quality standards. Project and Cross-functional Support Partner with Manufacturing, Engineering, QA, and Project Management to support tech transfers, equipment commissioning, and facility expansion initiatives. Participate in FAT/SAT, troubleshooting, and root cause investigations as needed. Candidate Must Have: Bachelor’s degree in Engineering or related field Min. 2 year of Hands-on Validation experience of Utility, process, equipment or cleaning systems Good people, communication skills to work in a team environment Experience with Sterile Aseptic Liquid Filling Operations in the Pharma Industry Ability to produce and present clear, concise, and professionally written communications and presentations. Candidate Nice to Have: Master’s degree in Engineering or Technical field Experience in engineering, ISO execution, Quality Systems, commissioning, and qualification preferred and is used to determine job level (I-IV). Startup or Small company experience working in a dynamic and hands-on role. Contract Manufacturing experience working closely with customers and clients Keywords:BioPharma, Pharma, Quality, Validation Equipment, Utilities, Process, cleaning, Sterile Aseptic filling, IQ, OQ, PQ, Protocols, pharmaceutical

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