Validation Engineer I

American Regent•New Albany, OH

About The Position

The Validation Engineer I develops and executes validation protocols and reports to support business needs. The role supports qualification and validation of pharmaceutical manufacturing processes, ensuring that facilities, systems, and processes perform according to internal specifications, comply with current GMPs, and remain in a validated state. Serving as a subject matter expert in a designated discipline, with a focus on Packaging, Equipment and Facilities, and/or Cleaning Validation, the incumbent develops and executes validation protocols for installation, operation, performance qualification, and requalification of equipment, utilities, and processes used to manufacture aseptically produced parenteral pharmaceuticals, including lyophilized products and solutions. The role also provides technical expertise during the design, evaluation, and procurement of new equipment, utilities, or processes and supports all phases of the Validation Life Cycle, from design through operation and improvement. The position plans and coordinates site-specific validation projects; maintains equipment and system lifecycle documentation; reviews qualification and requalification packages; coordinates protocol approvals; and prepares summary reports. It provides training, technical input on deviations and change requests, and support for SOP development. The incumbent remains current with FDA guidance and requirements for aseptic manufacturing validation and ensures work complies with company policies, procedures, cGMP, and health and safety requirements. The role works with Quality, Manufacturing, Packaging, and Engineering teams to execute and complete validation activities, and may perform other duties assigned by management.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or equivalent.
At least 1 year performing validation activities in the pharmaceutical, biopharmaceutical, or related life science industry.
Knowledge of cGMP regulations and practices relevant to validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations, and industry trends.
Strong knowledge of Microsoft Office software and PC skills.
Ability to read and interpret engineering drawings and design documents.
Good technical writing skills.
Excellent communication, problem-solving, planning, and organization skills.
Ability to work independently with minimal supervision, make sound decisions, and manage priorities in alignment with departmental and site directives.
Ability to work in a team-oriented environment.
Ability to work off hours and weekends.
Ability to wear cleanroom and protective gowning and equipment, including gowning, goggles, face shields, and protective gloves.

Responsibilities

Develop and execute validation protocols and reports supporting pharmaceutical manufacturing processes.
Qualify and validate facilities, systems, equipment, utilities, and manufacturing processes, and help maintain them in a validated state.
Serve as a subject matter expert in a designated discipline, focusing on Packaging, Equipment and Facilities, and/or Cleaning Validation.
Develop and execute installation, operation, performance qualification, and requalification protocols for equipment, utilities, and processes used in aseptic parenteral pharmaceutical manufacturing.
Provide technical expertise during the design, evaluation, and procurement of new equipment, utilities, and processes.
Maintain lifecycle documentation for equipment and systems, including User Requirements Specifications, Functional Specifications, Hardware Design Specifications, Software Design Specifications, and Configuration Specifications.
Support all phases of the Validation Life Cycle, from design through operation and improvement.
Plan and coordinate site-specific validation activities, including protocol development and approval, work schedules, and lifecycle documentation.
Review qualification and requalification packages for completeness, accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.
Provide and document training for personnel performing validation activities.
Provide technical input for validation deviations and assess change requests, identifying qualification requirements to ensure GMP compliance and maintain the validated state.
Coordinate protocol approvals and prepare accurate summary reports.
Develop or contribute to SOPs related to equipment or processes for which the incumbent serves as subject matter expert.
Remain current with FDA guidance and requirements for validation of aseptic manufacturing processes, and perform and document work according to company policies, procedures, cGMP, and health and safety requirements.
Provide technical and troubleshooting assistance to identify and address manufacturing anomalies or deviations.
Work with Quality, Manufacturing, Packaging, and Engineering groups to facilitate and drive validation execution and completion.
Perform other tasks or duties as assigned by management.