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 Albany, 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 Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Albany,NY.

Application Deadline This position is anticipated to close on Apr 24, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.