Validation Engineer I

American Regent, Inc.•New Albany, OH

About The Position

The Validation Engineer I develops and executes validation protocols and reports supporting company 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 GMP requirements, and remain in a validated state. Serving as a subject matter expert in a designated discipline, the engineer focuses on Packaging, Equipment and Facilities, and/or Cleaning Validation. The role 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. It also provides technical expertise for design, evaluation, and procurement of new equipment, utilities, or processes and maintains lifecycle documentation for equipment and systems. The engineer supports the validation lifecycle from design through operation and improvement; plans and coordinates site-specific validation activities; reviews qualification packages; provides and documents training; addresses validation deviations and change requests; coordinates approvals; and prepares summary reports. The role also contributes to SOP development, stays current with FDA guidance for aseptic manufacturing validation, assists with manufacturing anomalies and deviations, and works with Quality, Manufacturing, Packaging, and Engineering to complete validation activities.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or equivalent.
At least 1 year of experience performing validation activities in the pharmaceutical, biopharmaceutical, or related life science industry.
Knowledge and understanding of cGMP regulations and practices related to validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectations, and industry trends.
Strong knowledge of MS 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 aligned with departmental and site directives.
Ability to work in a team-oriented environment.
Ability to work off hours and weekends.
Physical ability to wear cleanroom and protective gowning and equipment, including gowns, goggles, face shields, and protective gloves.

Responsibilities

Act as a subject matter expert for a designated discipline, focusing on Packaging, Equipment and Facilities, and/or Cleaning Validation.
Develop and execute validation protocols for installation, operation, performance qualification, and requalification of equipment, utilities, and manufacturing processes.
Provide technical expertise during the design, evaluation, and procurement of new equipment, utilities, or processes.
Maintain lifecycle documentation for equipment and systems, including User Requirements Specifications, Functional Specifications, Hardware Design Specifications, Software Design Specifications, and Configuration Specifications.
Support the validation lifecycle from design through operation and improvement.
Plan and coordinate site-specific validation project 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 change-request assessments, and identify qualification requirements to ensure GMP compliance and maintenance of the validated state.
Coordinate protocol approvals and produce accurate summary reports.
Develop or contribute to SOPs for equipment or processes within the engineer’s area of expertise.
Remain current with FDA guidance and requirements for validation of aseptic manufacturing processes, and perform and document work in accordance with 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 and duties as assigned by management.