Validation Engineer

Position Summary The Validation Manager is responsible for leading validation strategy, execution, and lifecycle management for pharmaceutical or biotech manufacturing systems, with a strong focus on sterile processes. This role requires hands-on expertise in protocol authorship (IQ/OQ/PQ), project management, and compliance within a cGMP-regulated environment. The ideal candidate will independently drive validation activities, ensure audit readiness, and collaborate cross-functionally to support manufacturing operations. Key Responsibilities Lead end-to-end validation lifecycle activities including planning, protocol development, execution, and reporting for equipment, utilities, facilities, and processes Independently author and approve validation protocols (IQ/OQ/PQ) and final reports; ensure compliance with regulatory requirements Manage validation projects, timelines, and resources to meet business and regulatory objectives Provide technical expertise in sterile manufacturing processes, including vials, pre-filled syringes (PFS), and IV bags Collaborate with Engineering, Quality, Manufacturing, and Regulatory teams to ensure alignment of validation strategies Oversee change control processes, including initiation, impact assessment, implementation, and closure Lead deviation investigations and ensure effective CAPA implementation and closure Ensure all validation documentation meets cGMP, FDA, and international regulatory standards Support internal and external audits; act as a subject matter expert during inspections Continuously improve validation processes and compliance practices Required Qualifications Bachelor's degree in Engineering (Mechanical, Electrical, or related field); Master's degree preferred Minimum 5+ years of experience in pharmaceutical or biotech engineering and validation project management Proven experience in independent authorship of validation protocols (IQ/OQ/PQ) — not limited to review or support roles Strong hands-on experience executing validation protocols and generating reports Solid understanding of sterile manufacturing processes (vials, PFS, IV bags) Demonstrated experience managing change controls, deviations, and CAPA in a cGMP environment Experience in audit preparation and direct interaction with regulatory inspectors Preferred Skills Strong knowledge of FDA, EMA, and global regulatory requirements Excellent project management and organizational skills Ability to lead cross-functional teams and drive accountability Strong technical writing and documentation skills

Pay:

$80,000.00 - $100,000.00 per year

Benefits:

401(k) Health insurance Paid time off

Work Location:

On the road