The American Society of Mechanical Engineers (ASME)
4 days old
2018-06-132018-07-13

Sr. Principal Engineer- Miami, FL

Noven Pharmaceuticals
New York, New York 10118
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  • Job Type
    Employee
  • Job Status
    Full Time

 

Provides functional leadership and technical expertise for the design, implementation and qualification of new technology for the manufacturing processes, site utilities and facilities.  Lead and develop a team of engineers (manufacturing and qualifications) responsible for sustaining commercial activities and/or product development projects with a vision of a quality by design culture and continuous improvements. Assists manufacturing operations, facilities and utilities team 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.

Essential Functions

  • Perform as extension of engineering leadership staff providing direction to engineers and technicians, helping define direction and serve as example of Noven’s Mission, Values and Leadership Principles.
  • Lead a team of engineers-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.
  • Makes decisions independently on engineering problems and methods, and represents the organization in meetings, collaborations, conferences to resolve important questions and to plan and coordinate work.
  • 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.
  • Supervision and guidance related largely to overall requirements, critical issues, new concepts, and policy matters.
  • Consults with supervisor concerning unusual problems and developments.
  • Responsible for one or more of the following:

- In a supervisory capacity, plans, develops, coordinates, and directs 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. Provide technical support for key projects or department initiatives.

- Work is expected to result in the development of new or improved techniques or procedures. 

- Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods.

- Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.

  • Technically and/or directly supervise, coordinate and review the work of engineers and technicians, estimates manpower needs, project schedules and assigns work to meet completion date.
  • Lead new technology and automation projects, hands-on experience with PLC and SCADA software systems that control both intermittent or continuous motion line machines.
  • Practices company safety and quality policies and procedures.
  • 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 contracts.
  • Responsible for performing design reviews and pre-validation 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 (OEE) associated with machine maintenance, calibration and spare parts requirements is properly analyzed and then passed into the production, maintenance and calibration organizations.
  • Draft, review, and approve master validation plans, protocols, 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.
  • Has direct financial responsibility for definition, management and reporting of department’s capital and spend budget.

 

Extensive knowledge of regulatory requirements and engineering tools:

 

  • Risk Management (ICH Q9 or ISO 14971)
  • Draft, review, and approve master validation plans, protocols, 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.
  • Lean Six Sigma Principles and tools such as: Design of Experiments, Root Cause analysis and/or Problem solving approaches.
  • Strong understanding of GxP: Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP); Project Management principles; and ICH Q8, Q9, and Q10 procedures.
  • Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE) is strongly desired. Proficiency with Microsoft Word, Excel, Power Point and statistical software (e.g., Minitab) is required. Strong communication skills are required. Experience with organizational and operational excellence principles, delegation, influencing, strategic planning, and execution are desired.

 

Requirements

Bachelor’s Degree in Electrical Engineering or Mechanical Engineering.  MBA is a plus and Ten (10+) or more years of experience in a manufacturing operations and/or engineering/validation role of increasing responsibility, preferably in the pharmaceutical,  medical device manufacturing or healthcare environment.

Must possess the solid understanding of engineering fundamentals, engineering best practices, troubleshooting methodology, capital project management, process-utilities equipment validation.  

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 Excel required.  OEE (Overall Equipment Efficiency), Lean Sigma, TQM, Project Management and PLC’s - Controls experience a plus for executing smaller tasks, large projects and initiatives.  Experience with Business and Technical systems such as TrackWise, Master Controls, JDE, Minitab, AutoCAD and AutoDesk Vault a plus.

Travel:  Minimal travel domestically and internationally may be required; extra and unusual hours may be required to meet project deadlines.  Due to the nature and complexity of our operations and safety requirements it is required to be on call 24/7 per business needs.

 

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Sr. Principal Engineer- Miami, FL

Noven Pharmaceuticals
New York, New York 10118

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Noven Pharmaceuticals
New York, New York

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