·         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.

·         Develop and maintain quality engineering methodologies, systems, and practices which meet quality and regulatory requirements. Assure awareness, visibility, and communication to support departmental, functional, site, and corporate quality goals and priorities. Master Statistical Analysis, Product evaluations, Risk Analysis, investigations, qualification/validations as minimum to support Commercial Operations and R&D areas.

·         This individual works with minimum supervision using his/her experience, expertise, and sound knowledge to assure the quality of our systems, and products comply with NOVEN policies, procedures, and regulatory bodies’ guidance and regulations.

·         This individual will be expected to apply his/her knowledge of product, development principles, and quality engineering to develop procedures and processes that ensure sustaining activities and successful development of products to positively influence commercial and/or new product launches to ensure they are developed, validated / qualified, and manufactured in accordance with regulatory and quality requirements.

• Actively represents QE function on product development and manufacturing teams.
• Implementing ICH guidelines requirements with requisite elements of Q8, Q9 and Q10.
• Facilitate Quality Risk Analysis using appropriate risk management tools (eg. RMP, HA, U/D/P FMEA, FMECA, PHA, RMR etc.) 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 in 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, and/or approve, execute validation/qualification protocols and reports to ensure that the product design, evaluation, and testing is sufficient to meet Noven quality requirements, regulatory requirements and quality objectives.
• Promote the use of statistical and six sigma tools to determine root cause and actions implementation.
• Actively participates in the generation 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 the development, qualification, and on-going / continuous process verification to assure the manufacturing of products meet or exceed 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 performs Statistical Analysis of products under commercial manufacture
• Performs training and provide technical support
• Actively participate in the implementation of computerized /paperless systems (eg. 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 Review, post market surveillance, and other product and process lifecycle reports.

Sound knowledge of quality tools using:

• Pharmaceutical development (ICH Q8(R2))
• Risk analysis (ICH Q9 or ISO 14971)
• Pharmaceutical Quality System (ICH Q10)
• EMA/CHMP/QWP/608924/2014 - Guideline on quality of transdermal patches
• Industrial use in applied statistical techniques and statistical analysis software (e.g. MiniTab, SIMCA-Q)
• Lean Six Sigma Principles and/or Operational Excellence
• Strong understanding of GxPs Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP); Project Management principles; and ICH Q8, Q9, and Q10 procedures.

Other Elements

Education & Experience:

A minimum of a bachelor’s degree in science or engineering or associated fields is required. Mechanical, Biomedical, or Chemical Engineering preferred. Bachelor’s degree in other Engineering or Science discipline with relevant equipment understanding. A minimum of 5 years of experience in Quality Engineering performing equipment qualifications and process validations. Experience in transdermal systems or combination products preferred. Strong written/verbal communication skills. Demonstrated use of Quality tools and methodologies in a pharmaceutical, medical device, or biotech sector. Applied Statistical analysis, Statistical Analysis software experience and expertise. Certified Quality Engineer (CQE) desired. High proficiency with Microsoft Word, Microsoft Excel, Power Point and statistical software packages (e.g., Minitab) is strongly desired. Strong documentation skills are required. Master’s degree in Engineering preferred.

Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.

Supervisory Responsibilities:

N/A

Travel:

Less than 10%

Working Conditions

Work Environment:

Air-conditioned office environment.   Some time spent in the laboratories and manufacturing with exposure to chemicals and moving parts.

Physical Demands:

Visual acuity and manual dexterity required to review documents and operate a computer.