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The Senior Validation Manager is leading the site validation program and all qualification and validation activities at the Erytech, Princeton site, NJ. Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you will define, implement and maintain the validation program for the site, ensuring compliance to the company quality guideline, FDA regulatory requirements, and cGMP regulations.

RESPONSIBILITIES

• The ideal candidate will have strong understanding of risk-based approach to validation, related to aseptic process and environmental control and extended experience with risk assessment including FMEA and AMDEC.
• Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality teams.
• Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
• Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality team.
• Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
• The role includes writing, reviewing and coordinating documents required for Commissioning/Qualification/Validation such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in a cGMP manufacturing environment.
• Lead the overall validation strategies and validation master plans.
• Compile validation packages and ensure all required documentation is complete.
• Responsible for the implementation and execution of the periodic system reviews and requalification activities.
• Lead investigation related to deviations and discrepancies with impact on validation.
• Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
• Develop and maintain CQV SOPs related to equipment, facility, and computerized systems.
• Assist in presentation of validation packages during inspections or audits.
• Participate, as required, in the response to regulatory audit observations.
• Recognizes potential safety and compliance problems and takes actions to rectify them.

QUALIFICATIONS

• Bachelor’s degree in Engineering, Science, or related technical field.
• Minimum 10 years applicable experience of CQV activities in a cGMP manufacturing environment and on aseptic processes.
• Expert in Quality Risk Management (Performing Risk assessments and using results for determination of test strategies).
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) related to validation in a cGMP facility.
• Experience using statistical, risk assessment, and process improvement tools.
• Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator.
• Ability to plan and execute Smoke / Airflow Visualization Studies.
• Ability to recommend, judge, and make good decisions in complex situations.
• Strong organizational skills, excellent writing, and communications skills. Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
• Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality teams.
• Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
• The role includes writing, reviewing and coordinating documents required for Commissioning/Qualification/Validation such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in a cGMP manufacturing environment.
• Lead the overall validation strategies and validation master plans.
• Compile validation packages and ensure all required documentation is complete.
• Responsible for the implementation and execution of the periodic system reviews and requalification activities.
• Lead investigation related to deviations and discrepancies with impact on validation.
• Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
• Develop and maintain CQV SOPs related to equipment, facility, and computerized systems.
• Assist in presentation of validation packages during inspections or audits. Participate, as required, in the response to regulatory audit observations.
• Recognizes potential safety and compliance problems and takes actions to rectify them.

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