Quality/Validation Engineer

Pride Health is seeking a Quality/Validation Engineer for a global biopharmaceutical leader that specializes in developing and manufacturing therapies for people living with rare and serious diseases. The role involves writing and executing validation documentation, conducting quality control analyses, and ensuring compliance with regulatory standards.

Responsibilities:

• Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products and/or processes
• Conducts quality control for statistical analyses of testing results and process anomalies
• Ensures that corrective measures meet acceptable reliability standards
• Verifies calibration, maintenance, and repair of instruments as applicable to support the Quality Systems validation program
• May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements
• Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA's guidance on Validations, all relevant Medical Device Directives, and other applicable standards
• Under direct supervision, assists in preparation, execution, data collection, and reporting of validation studies to ensure the user needs and specifications are consistently met
• Prepares validation protocols and test equipment; evaluates validation test data
• Prepares reports on completed studies that summarize test results and their conformance to defined acceptance criteria
• Assists in developing programs and maintaining standard operating procedures (SOPs)validations
• May provide support related to management of procedural documents
• Communicates cross functionally regarding needs and status of assigned study activities and project deliverables
• Perform other job-related duties as assigned

Requirements:

• Bachelor's degree in sciences or engineering or equivalent combination of education, training and relevant work experience required
• 3+ years' related quality/validation experience in pharmaceutical manufacturing/a highly regulated industry
• In-depth working knowledge of cGMP principles and applications
• Demonstrated ability writing and approving documents, which help explain technologies, processes and products including validations
• Participating in FMEA or RCA/CAPA development teams
• Understand regulatory standards, various local, state, and federal laws that apply to the business and where to find information on standards and interpretations
• Excellent negotiating, critical reasoning, decision-making, and problem-solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects
• Strong project management and organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
• Strong written and verbal communication, interpersonal and presentation skills to drive results
• Establish solid working relationships to interface with other business units, third parties and other positions and circumstances within the organization
• Demonstrates excellent customer service skills with the flexibility to respond to changes quickly
• Maintain a professional demeanor and handle confidential information with discretion
• Computer literate with proficiency in office applications, word processing, spreadsheets, graphics and statistical programs, and use of electronic quality and operational systems
• ASQ Certification