Quality Engineering Manager - FWN

The expectation of this role is to be a working manager who provides organization, direction, and oversight to the Quality Engineering team while continuing to be actively engaged in high priority project oversight and process improvements.

Safety/Housekeeping – Ensure work areas comply with applicable standards (HSE, GMP, etc.), and that associates are working safely.

  • Promote/reinforce company and department HSE standards, through regular communication, training, and reminders
  • Ensure associates work according to established standards and SOPs; engage associates to adjust behaviors as needed
  • Ensure work areas are clean and safe, and audit-ready at all times
  • Continuously monitor work areas; identify, resolve, and report safety hazards
  • Ensure materials are handled and disposed of properly, per HSE standards
  • Evaluation of safety risk design for engineering changes and new equipment

Planning – Provide coordination of changing workload and priorities for self and team.

  • Plan and schedule self and associate work activities based on fair workload distribution, SME development and leverage of existing expertise, changing priorities and to facilitate ownership and accountability
  • Communicate company and department objectives to team
  • Develop team objectives (people, safety, quality, supply, cost, etc.), and gain agreement from management
  • Monitor progress on team objectives, and communicate results to associates and management
  • Maintain schedule of daily, weekly, and monthly work activities (e.g., deadlines, reports).

Technical – Analyze and improve the engineering quality of production processes and products through accurate root cause assessment and effective corrective actions. Improve the customer experience through continuous improvement of engineering design and risk reduction.

  • Provides overall direction and oversight for the Quality Engineering team in the development, maintenance, and compliance of Quality Systems directly related to manufacturing and packaging operations.
  • Manages the oversight of non-conformance investigations and implementation of corrective and preventive actions while assuring there are adequate product and process controls in place for identified CTQs.
  • Performs evaluations of process quality and performance attributes to identify continuous improvement initiatives related to Quality Systems and process control infrastructure to ensure continued sustainability of manufacturing operations and products.
  • Actively participates in and contributes to routine engineering and manufacturing-based meetings, including presentation of metrics, process challenges, Quality-related initiatives, etc.
  • Provide a source of consistent quality oversite in regards to the engineering lifecyle and change control. This includes; proper matrixed validation approach, attribute inspections, exception handling, proper order of operations, timely closure, appropriate validation paths, reviews of holistic validation packages.

o PPC (Product or Process Change)

o URS/FRS (User Requirement Specification/Functional Requirement Specification)

o SDD (Software Design Document)

o ECO (Engineering Change Order)

o FAT (Factory Acceptance Test)

o Project VMPs (Validation Master Plan)

o TMD (Traceability Matrix)

o IOQ (Installation Operation Qualification)

o PQ (Performance Qualification)

  • Ensure consistent application of GDP and DI on all documentation.
  • Streamline change control and Automation Lifecycle Management process.
  • Lead high-profile investigations and author deviation documentation
  • Initiate Engineering Change Control (ECO) and Product Process Change (PPC) documentation
  • Supervises product designs and redesigns associated with sustaining and recapitalization of product lines.
  • Assists in new product development to ensure compliance with company, customer and industry standards.

Team – Provide a fulfilling work environment that engages teams and enables strong performance. Set direction for associates to know what is expected, and why.

  • Hire, train, coach, and evaluate associates
  • Help create and maintain organization and structure within the department
  • Plan/assign duties, tasks according to their KSAs (Knowledge, Skills, and Abilities), so that work assignments are carried out timely and effectively
  • Evaluate the performance of associates, and celebrate successes
  • Provide regular encouragement and feedback, both formal and informal
  • Assess the KSAs of individual associates and of the entire team. Ensure training plans and development activities grow KSAs of individual associates, and the overall capability of the team
  • Be attentive to employee needs and concerns. Resolve complaints involving individuals or multiple associates
  • Collaborate with HR to correct performance and behavior problems through counseling and disciplinary action
  • Act as a role model for company values and behaviors
  • Adapt schedule to flexible work hours
  • Acts as a coach for the technical members of the quality engineering department to maximize individuals' technical abilities and creativity.
  • Mentor Automation Engineers and Validation Scientists, and Contractors on change control procedures and best practice

Interfaces – Interact with internal and global stakeholders at all levels within the organization concerning critical investigations and engineering changes.

  • Leadership role in the Change Control Review Board
  • Partnership with Automation Engineering / Validation on design specifications, risk management, quality engineering concept, software life cycle management and qualification / validation.
  • Work with Production, Engineering, and MS&T on complaint investigations, root cause determination, and institution of Corrective and Preventive Actions EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Minimum Education / Experience:
  • Bachelor's Degree in a scientific technical discipline (preferable engineering or computer science)
  • 7+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, audit experience, Lean Six Sigma, computerized system knowledge, product and process validation, trending, and change control
  • 5+years leading people at various levels and coordinating cross-functional teams
  • Microsoft Office Suite with advanced Excel charting experience and statistical analysis capability
  • Proven problem solving skills, and ability to meet deadlines under pressure
  • Well organized, with good time-management skills, ability to build rapport

Desired Experience:

  • Understanding of GAMP 5
  • Previous experience drafting/executing FAT, DQ, IOQ, PQ, VMP documents
  • Previous experience in the definition of equipment qualification approach and SOPs
  • Technical understanding of aseptic process, filling, packaging equipment.
  • Strong GMP Documentation Skills
  • Above average understanding of Manufacturing / Production Principles
  • Strong computer skills, including Microsoft Word, Excel, Power Point, and Project
  • Excellent organizational skills
  • Ability to manage multiple priorities

Fluent in English

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