Qualification & Validation Engineer (m/f/d)

EPM Scientific is supporting a client who is looking for a Qualification & Validation Engineer with experience in sterile manufacturing. This role offers the opportunity to support qualification, validation, and calibration activities within a GMP-regulated aseptic production environment while collaborating with cross-functional teams to ensure compliance, operational excellence, and inspection readiness.

See a summary of the role below:

Role Overview

• Support qualification, validation, and calibration activities for equipment, facilities, utilities, cleanrooms, and HVAC systems used in sterile manufacturing operations

• Coordinate and execute qualification and requalification projects to ensure ongoing GMP compliance and operational readiness

• Plan, prepare, and support aseptic process simulations and other validation studies within the manufacturing environment

• Collaborate cross-functionally with Production, Engineering, Quality Assurance, and external vendors to deliver validation activities on schedule

• Maintain the validated state of manufacturing systems through risk-based lifecycle management and continuous improvement initiatives

Key Responsibilities

• Plan and execute qualification, requalification, validation, and calibration activities across manufacturing equipment, facilities, utilities, cleanrooms, and HVAC systems

• Prepare, review, and approve qualification and validation documentation, including protocols, reports, risk assessments, and standard operating procedures

• Lead and coordinate aseptic process simulations and support investigations arising from validation activities where required

• Support regulatory inspections, customer audits, and internal audits by providing validation-related expertise and documentation

• Monitor validation schedules and ensure activities are completed in accordance with GMP requirements and internal quality standards

• Participate in qualification and validation projects associated with equipment upgrades, facility modifications, process improvements, and new technology implementation

Requirements

• Degree in Biotechnology, Pharmaceutical Sciences, Process Engineering, Pharmaceutical Technology, Life Sciences, or a related technical discipline

• Proven experience within a GMP-regulated sterile manufacturing or aseptic production environment

• Hands-on experience with qualification and validation of equipment, facilities, utilities, HVAC systems, and cleanroom environments

• Knowledge of aseptic processing principles, media fills, contamination control strategies, and relevant regulatory requirements

• Experience preparing and reviewing validation lifecycle documentation and managing validation projects

• Previous exposure to regulatory inspections, customer audits, or health authority interactions is advantageous

• Strong organizational and communication skills with the ability to work effectively across cross-functional teams

If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.