Senior Engineer, Validation Commissioning

About the Role

An engineering professional who collaborates with project owners, subject designers/engineers, and other project team members to plan and complete tasks related to commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, and processes. The role ensures alignment with project, operations, and quality objectives, focusing on establishing evaluation, testing, and documentation for risk management, commissioning, and validation while applying product and regulatory requirements.

Responsibilities

• Work with end-users and project engineers to develop User Requirements Specifications and Functional/Design Specifications for new or modified equipment, facilities, and utilities.
• Support Factory Acceptance Testing alongside the Project Engineer to confirm unit acceptability.
• Identify risk controls, critical elements, and traceability of equipment design based on FMEA or other risk assessments.
• Develop and execute commissioning, qualification, and validation test protocols to ensure unit functionality aligns with specifications.
• Perform minor troubleshooting of issues encountered during commissioning and document unresolved issues.
• Support broader project aspects, including project leadership, developing operational procedures, training maintenance/technical staff/operators on new equipment, reviewing product documentation for compatibility, and implementing changes in equipment parameters or recipes.
• Lead execution of Risk Management, including periodic reviews and updates per the Validation Master Plan, interfacing with best practices, and establishing team work practices (e.g., overall program, ccRA).
• Demonstrate success in FMEA authorization/facilitation and qualify as a QRM facilitator commensurate with responsibility.
• Supervise contract validation resources to ensure timely completion of activities in the assigned area of responsibility.

Requirements

• Bachelor’s Degree in Engineering, science, or a closely related discipline (desired), or equivalent technical experience plus demonstrated competence.
• 3+ years of significant engineering and/or operational experience.
• Experience developing commissioning, qualification, validation, and risk management deliverables, including specifications and testing protocols that meet regulatory scrutiny.
• 6+ years of overall experience in Manufacturing, Quality, or Engineering, with exposure to at least 4 major validation subjects (e.g., Computer, Equipment, Cleaning, Process).
• Technical background in healthcare, nutritional products, laboratory diagnostics, medical devices, pharmaceuticals, or similar industries (preferred).
• Strong interpersonal, communication, and negotiation skills with a demonstrated ability to work in a team environment.
• Knowledge of quality/compliance management, as well as regulations and standards affecting API, Bulk Drug, or Finished Goods manufacturing (preferred).
• Ability to supervise junior or contract team members (prior supervisory experience preferred).
• Ability to manage complex and multiple projects (5+) simultaneously.

Benefits

• Paid time off (vacation, holidays, sick leave).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in short-term incentive programs.