VALIDATION ENGINEER IV

Essential Duties And Responsibilities

• Author validation plans; oversee and provide direction in the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ Protocols.
• Review and approve commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
• Provide direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
• Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables.
• Perform a periodic review of systems to monitor the validation status of the system as well as write and develop validation SOPs.
• Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
• Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities.
• Cook up and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping manager regularly updated.
• Write protocols and technical study approaches.
• Review document changes for validation impact.
• Review deviation reports for validation impact.
• Review and approval of change controls.
• Propose corrective actions to validation manager and appropriate departments and implement the required changes.

Professional Skills

• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
• Possess strong knowledge of commissioning, qualification validation and related practices, including applicable regulations.
• Excellent technical writing, verbal communication and presentation skills.
• Technical understanding of pharmaceutical/biotechnology unit operations.
• Ability to evaluate compliance issues.
• Strong skills in team development and leadership.
• Successful demonstration of collaboration with validation management, and project teams.
• Proficiency in Microsoft Office including Word, Excel, Power Point, Project.

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline required with a minimum of eight (8) years of Pharmaceutical industry experience or combination of work experience in Validation, Quality, Production, or Engineering.
• Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
• Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
• Direct Validation experience with pharmaceutical or biopharmaceutical processes including the development of strategies, master plans, protocols and reports.
• Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Sterilization.
• Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.