Quality Engineer

Associate Director - Talent Acquisition at Noven Pharmaceuticals

The primary purpose of this position is to lead Quality Engineering (QE) activities for product and process support including Validation of Manufacturing Processes, Cleaning Processes, and Test Methods, Qualification of Equipment, Utilities, and Facilities, Risk Management, and Annual Product Reviews. This role develops and maintains quality engineering methodologies, systems, and practices that meet quality and regulatory requirements. It ensures awareness, visibility, and communication to support departmental, functional, site, and corporate quality goals and priorities.

The incumbent must master statistical analysis, product evaluations, risk analysis, investigations, and qualification/validation to support Commercial Operations and R&D areas.

Working with minimal supervision, the individual uses experience, expertise, and sound knowledge to assure that systems, products, policies, procedures, and regulatory guidance of NOVEN are followed. They apply product development principles and quality engineering to develop procedures and processes that support sustaining activities and successful development of products, positively influencing commercial and new product launches in accordance with regulatory and quality requirements.

• Actively represents QE function on product development and manufacturing teams.
• Implement ICH guidelines requirements with requisite elements of Q8, Q9 and Q10.
• Facilitate Quality Risk Analysis using appropriate risk management tools (e.g., RMP, HA, U/D/P FMEA, FMECA, PHA, RMR) in accordance with ICH Q9 and ISO 14971:2019 requirements.
• Draft and execute protocols for equipment, utilities, and facilities qualification for adequateness to the manufacturing processes. Support supplemental documentation such as functional specifications, system risk assessment, and system impact assessment.
• Perform process validation, cleaning validation, and test method validations in accordance with FDA and Noven requirements.
• Generate, review, approve, and execute validation/qualification protocols and reports to ensure product design, evaluation, and testing meet Noven quality requirements, regulatory requirements and quality objectives.
• Promote the use of statistical and six sigma tools to determine root cause and implement actions.
• Participate in generating quality characteristics, process or product specifications, inspection plans, and control strategies during development for components, raw materials, and new finished products.
• Identify and implement effective process control systems to support development, qualification, and ongoing continuous process verification to ensure manufacturing of products meets or exceeds internal and external requirements and is maintained in a state of control.
• Apply sound, systematic problem‑solving and lean six sigma methodologies for identifying, prioritizing, communicating, and resolving quality issues.
• Support development, implementation and deployment of quality initiatives (e.g., APQR, Quality by Design, Risk Analysis and Process Analytical Technology).
• Develop and/or write Continuous Process Verification, Annual Product Review (APR) reports, and/or perform statistical analysis of products under commercial manufacture.
• Perform training and provide technical support.
• Participate in the implementation of computerized/paperless systems (e.g., LIMS, MES) by providing guidance on the requirements for ICH Q10, APQR, QbD, and CPV.
• Update quality systems for all stages of product development including but not limited to product engineering/development, prototype testing, and commercialization.

• Drive Quality first within all facets and phases of development and sanction QE metrics across the organization.
• Collaborate closely with product development and manufacturing to deliver high quality products to our customers.
• Draft and implement specification, procedures, master validation plans, protocols, and reports for product life cycle, sustaining commercial activities including qualification protocols and reports.
• Carry out Continuous Process Verification (CPV), Annual Product Quality…