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.
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