Validation Engineer

Job Title:

Validation Engineer

Job Description We are seeking a hands-on Validation Engineer to implement, validate, and continuously improve manufacturing processes within our sterile compounding facility. This role is central to bridging engineering, quality, and production, ensuring that all equipment, utilities, cleanroom systems, and manufacturing processes are qualified, validated, and maintained in a state of compliance with FDA regulations and USP standards. Responsibilities
* Author, review, and execute IQ/OQ/PQ protocols for manufacturing equipment, utilities, and cleanroom systems.
* Lead process validation activities for sterile compounding operations including sterilizing filtration, aseptic filling, and terminal sterilization processes.
* Develop and execute cleaning validation protocols for product-contact equipment and cleanroom surfaces.
* Perform equipment commissioning, FAT/SAT, and turnover to production.
* Support Computer System Validation for electronic QMS, MES, ERP, and environmental monitoring systems.
* Design, optimize, and document sterile manufacturing processes including API dissolution and aseptic fill operations.
* Develop and maintain process flow diagrams, P&IDs, and critical process parameter specifications.
* Perform process risk assessments to identify and mitigate risks to product quality and patient safety.
* Conduct root cause analysis and implement corrective actions for process deviations and equipment failures.
* Drive continuous improvement initiatives using Lean, Six Sigma, and statistical process control methodologies.
* Support qualification and ongoing monitoring of ISO-classified cleanroom environments.
* Oversee utility system qualification and monitoring.
* Support environmental monitoring program design and data trending.
* Author and maintain engineering SOPs, validation master plans, protocols, and technical documentation.
* Ensure all engineering activities comply with applicable regulatory guidance.
* Maintain audit-ready validation files and support audits and inspections.
* Participate in change control, deviation investigations, and CAPA processes.
* Partner with Production, Quality Assurance, and Quality Control to ensure validated processes translate to reliable manufacturing operations.
* Support training of production operators on equipment operation and process parameters.
* Coordinate with external vendors, contractors, and equipment suppliers. Essential Skills
* Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Pharmaceutical Engineering, or related discipline.
* 2 to 5 years of experience in a cGMP-regulated manufacturing environment.
* Hands-on experience authoring and executing IQ/OQ/PQ validation protocols.
* Strong knowledge of FDA cGMP regulations, validation lifecycle methodology, and risk assessment tools.
* Experience with equipment qualification and process validation in a manufacturing setting.
* Solid understanding of cGMP documentation practices and data integrity principles.
* Strong analytical and problem-solving skills.
* Proficiency with Microsoft Office Suite; experience with statistical tools is a plus.
* Excellent written and verbal communication skills. Additional

Skills & Qualifications
* Experience in a 503B outsourcing facility or sterile pharmaceutical manufacturing environment.
* Knowledge of cleanroom operations and USP //.
* Experience with utility system qualification and environmental monitoring.
* Familiarity with 21 CFR Part 11 and electronic QMS/MES platforms.
* Lean Six Sigma Green Belt or equivalent certification.
* Experience with sterilizing filtration, aseptic processing, or autoclave validation.
* Bilingual (English/Spanish) is a plus. Work Environment This role operates in a startup-scale environment where you will have the opportunity to build systems from scratch. The position requires wearing multiple hats and taking on various responsibilities. The work involves being in cleanroom environments with full gowning, lifting up to 40 lbs, and working around manufacturing equipment. You will be part of a rapidly expanding organization where engineering excellence directly drives business success.

Job Type & Location This is a Contract to Hire position based out of Colonie, NY. Pay and Benefits The pay range for this position is $50.00 - $65.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee…