Senior Validation Engineer (pharma) We are seeking a Senior Validation Engineer who will be responsible for managing, developing, and implementing Equipment and Facility Validation programs to support pharmaceutical, biological and health system manufacturing initiatives ensuring compliance with regulatory agency requirements, internal company standards, and current industry practices. Job Responsibilities: --- Design, develop and lead equipment, and facility validation initiatives. --- Ensure that the Validation Master Plan remains current.
--- Write, review, and execute Equipment and Facility Validation protocols to ensure compliance and adherence to GMP and Client validation standards. --- Initiate a problem report change control, in a TrackWise system. --- Resolve all non-conformances/deviations and prepare a final summary report for Equipment/Facility Validation protocols.
--- Liaise with manufacturing and laboratory groups in the execution of the Validation program. --- Communicate the Equipment and Facility Validation approaches and requirements during audits. --- Facilitate a continuous improvement culture within the Manufacturing, Engineering, and Quality Control/Assurance environments.
--- Generate and maintain Validation procedures in line with corporate guidelines procedures, GMP, and ISPE standards. --- Work collaboratively to meet Equipment and Facility Validation deadlines, write reports, give presentations, and maintain knowledge and information in the area of expertise. --- Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication.
--- Anticipate and assess/prevent technical problems from impacting products and processes. --- Achieve results through the development/optimization of people, processes, and system requirements to harness the creativity of multi-disciplined teams. --- Represent Quality and validation for New Product Development and Release to Manufacturing activities.
--- Manage Validation contractors to complete on-site validation if required. --- Comply with Health, Safety, and Environmental responsibilities for the position. Other tasks as assigned.
Education: Experience: Degree (Bachelors or Masters) in a technical discipline. Preferred Five (5) to seven (7) years in a CGMP-related industry with at least three (3) to four (4) years of validation industry experience. Employment Type: Full Time Years Experience: 5 - 10 years Salary: 100.00 Hourly Bonus/Commission: No
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