Validation Engineer

Position Overview

The Validation Engineer will be responsible for leading validation activities for assigned projects within a regulated manufacturing environment. The role encompasses the full validation lifecycle, from requirements definition and design review through qualification, process validation, change management, and eventual system decommissioning.

Projects may span manufacturing and facility systems, aseptic formulation and filling, medical device assembly, packaging, automation, laboratory systems, and facility infrastructure.

Key Responsibilities

• Develop, revise, and maintain validation documentation in accordance with project requirements, quality standards, and applicable regulatory expectations.
• Author, execute, and prepare reports for Design Review/Qualification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation activities, as applicable.
• Support commissioning and qualification activities to ensure systems and equipment are ready for validation execution.
• Participate in Factory Acceptance Testing (FAT) and other supplier qualification activities as required.
• Manage and track validation deliverables for assigned projects and provide routine status updates, risks, issues, and escalations to project leadership.
• Identify, investigate, and document deviations, discrepancies, and engineering changes encountered during validation activities.
• Initiate, author, and/or support change controls and assess the validation impact of proposed changes.
• Use approved electronic quality and document management systems to create, revise, route, execute, and maintain validation and change-control documentation.
• Ensure validation deliverables comply with applicable GMP requirements, FDA regulations, EU Annex 15, GAMP 5 principles, and site quality procedures.
• Collaborate with Engineering, Manufacturing, Quality, Automation, Operations, and external suppliers to coordinate validation activities and resolve project issues.
• Support project teams throughout the validation lifecycle, including turnover to operations and system closeout or decommissioning activities.

Preferred Experience

Candidates will be assigned to projects based on their technical expertise and relevant validation experience. Experience in one or more of the following areas is preferred:

• Manufacturing equipment upgrades and production-line modifications, including:
• Aseptic formulation and filling equipment
• Restricted Access Barrier Systems (RABS)
• Vision inspection systems
• Medical device assembly equipment
• Packaging equipment
• Process control and manufacturing execution systems, including SCADA, PLC, MES, and related automation platforms.
• Laboratory systems and GMP facility modifications.
• Process instrumentation, monitoring, and calibration systems.
• Building Management Systems (BMS), HVAC, refrigeration, and facility utility systems.
• Electrical distribution, switchgear, controls, and related infrastructure.
• Physical security, access control, and CCTV systems.
• Technology modernization, equipment replacement, and lifecycle-management initiatives.
• Authoring and executing electronic validation documentation within regulated environments.
• Experience working within GMP-regulated pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Experience supporting cross-functional capital projects from design through implementation, qualification, and operational turnover.

Regulatory & Quality Knowledge

Successful candidates should have working knowledge of applicable requirements and industry practices, including:

• Current Good Manufacturing Practices (cGMP)
• FDA regulations and guidance
• EU GMP requirements, including Annex 15
• GAMP 5
• Risk-based validation principles
• Change control and deviation management
• Electronic documentation and data integrity expectations