• Qualification Engineer III

    Job Locations US-FL-Miami
    Job ID
    2018-1315
    Type
    Full Time Regular
    Category
    Engineering-All Disciplines
    FLSA Status
    Exempt
    Work Shift
    1st Shift
  • Overview

    The Qualification Engineer III is a professional who understands and provide technical expertise in the manufacturing process, site facilities and utilities. He or she is responsible for designing, developing and maintaining robust qualification system in order to fulfill Noven Pharmaceuticals, Inc. standards and procedures, regulatory requirements and cGMP regulations and guidelines. Oversee the design, implementation and qualification of new technology for manufacturing processes, site utilities and facilities.  Responsible for executing multiple projects, on both a large and small scale, sustaining commercial activities and/or product development projects with a vision of a quality by design culture and continuous improvement. Assists manufacturing operations, quality, facilities and utilities teams in troubleshooting and problem solving with regards to materials, components, equipment and systems.  Develops and recommends technologies to achieve cost effectiveness, improved product quality and reliability.  Recommends processes for the production of therapeutic products using tankage, piping, coating /oven systems, laminating dies, pouching machines, packaging, facilities and utilities (compress air, chillers, cooling towers, HVAC, etc.) systems.

    Responsibilities

    • The Qualification Engineer III is instrumental in the design, schedule, execution, and evaluation of scientifically and statistically sound qualification experiments which define and demonstrate that critical Controls, Equipment, Facilities, Processes, and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements and policies affecting final product integrity.
    • Assist the Engineering Department in developing policies, programs, SOPs to meet current industry standards, Quality, and external Regulatory requirements.
    • Serve as Subject Matter Expert (SME), reviewer, or approver of controlled documents and investigations within area(s) of expertise.
    • Teamwork with engineers, scientist, technicians from different technical disciplines in broad areas of assignments. Establishes operating equipment specifications, optimize manufacturing techniques, improve equipment reliability and establish automation technology road map.
    • Applies knowledge of engineering principles and practices in broad areas of assignments and related fields. Apply knowledge of compliance, risk management, and good engineering practices.
    • Requires the use of advanced techniques and the modification and extension of theories, precepts and practices of his/her field and related sciences and disciplines. Knowledge of materials, their chemical/structural properties, and material handling.
    • Lead small to large critical engineering projects (process, packaging, utilities and facilities) and/or a number of small projects with many complex features from definition to its implementation. As an individual researcher, carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
    • Provided guidance to R&D teams in process development to assure quick and successful qualification and transfer of processes to Manufacturing.
    • Demonstrates the ability to multitask and provides a thorough understanding of the work performed.
    • Prepares, reviews, and executes process, facilities, utilities and engineering qualification protocols, reports, and other relevant documents as they pertain to specific qualification requirements.
    • Plans, conducts, and supervises, documents and reports for process, facilities-utilities and software (CSV) qualification activities in order to maintain documentation in compliance.
    • Interfaces directly with key functional groups internal and external to the local site to obtain the necessary information and support for development of qualification documents or protocols (URS, FAT, SAT, Commissioning, IQ, OQ, PQ, Etc.).
    • Collates all data associated with a qualification and compiles the final qualification report for approval.
    • Maintains the site Validation Master Plan (VMP) and performs periodic process review and re-qualification to ensure continued compliance.
    • Verifies that the qualification studies have been adequately recorded and documented in accordance with the approved master qualification plan(s) and qualification protocols.
    • Maintains all qualification documentation in accordance with site quality system requirements.
    • Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately justified, documented and fully addressed.
    • You will help to demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.
    • Lead new technology and automation projects, hands-on experience with PLC and SCADA software systems that control both intermittent or continuous motion line machines.
    • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, code compliance, policies and procedures for Health, Safety and Environmental compliance.
    • Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company and or outside entities. Select and monitor outside vendors, contractors; negotiate fabrication, timelines, task orders and contracts.
    • Responsible for performing design reviews and pre-qualification assessments to ensure the safe and environmentally sound start-up of new processes. Supervise and execute factory acceptance test (FAT), site acceptance test (SAT), installation, commissioning and qualification activities of new and existing equipment.
    • Ensure equipment related information such as trends, issues, availability, performance, and quality associated with machine maintenance, calibration and spare parts requirements is properly analyzed and then passed into the production, maintenance and calibration organizations.
    • Authors, draft, review, and approve master qualification plans, protocols, change controls and reports for product life cycle and sustaining commercial activities.
    • Support complaint investigations for root cause and CAPA implementation with statistical and six sigma tools to determine root cause.
    • The Engineer will continually ensure systems, equipment and facilities comply with regulatory and Quality process requirements.
    • Familiarity with ISPE Baseline Guide 5: Commissioning and Qualification and validation Risk Based approaches.
    • Support complaint investigations for root cause and CAPA implementation with statistical and six sigma tools to determine root cause.

    Qualifications

    Competencies:

     

    Education & Experience:

    BS in Mechanical, Electrical, Industrial or Chemical Engineering or a related engineering discipline with 5-9 years of experience and/or training; Experience in the pharmaceutical or medical device industries (preferred).  Must possess the solid understanding of engineering fundamentals, engineering best practices, troubleshooting methodology, project management, process-utilities equipment qualification.  Enhance knowledge of cGMPs, pharmaceutical / medical device manufacturing methods, and validation principles.

     

    Good written and oral English communication skills. Computer literate a must, strength with Statistics used for Design of Experiments as well as MS Project and AutoCAD required.  OEE (Overall Equipment Efficiency), Certified Lean Six Sigma, TQM, Project Management experience for executing smaller tasks, small-medium projects and initiatives.  Experience with Business and Technical systems such as TrackWise, Master Controls, JDE, Minitab, and AutoDesk Vault a plus. Good written and oral English communication skills.

     

    Judgment / Decision Making:   

    Self-starter and must be able to work with minimum supervision. Works on complex problems of diverse scope where analysis of data requires an in-depth evaluation of various factors.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.  Work will often be performed within a cross functional framework and will involve the development and writing of quality policies, procedures, etc.  A high degree of original thinking, resourcefulness and networking will be required to coordinate projects or solve problems.

     

    Responsibilities for Contacts:   

    Frequent internal contact with all levels and functions of personnel.  Contact with vendors, customers, contractors, partners, and Health Authority Inspectors during audits/inspections to exchange information, coordinate projects, and negotiate solutions.

    The ability to work in and communicate well within a team structure in multiple projects, thrive in a fast-paced environment and adapt to changes with a positive attitude is required. Must be able to work in a fast paced environment, and have excellent communication and emotionally intelligence skills.

     

    Environment:

    Time distributed between office and Product Development / Operations / Facilities / Utilities environment with exposure to moving parts, mechanical rooms and noise.

     

    Physical Demands: 

    Regularly stands for more than two hours at a time, with some stooping and bending. Visual acuity and manual dexterity required to operate computer, and proofread documents.

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