Valeant Pharmaceuticals

Principal Engineer Facilities

US-FL-Tampa
Job ID
8545
Pos. Category
Operations
Pos. Type
Full Time

Overview

The person in this position is the subject matter expert in aseptic manufacturing facilities and related utilities and has the ability to make decisions with high liability.

 

Under the direction of the U.S. Engineering and Tampa Site Leadership teams, the Principal Engineer will support and/or lead multiple site-based capital projects inclusive of process equipment, utilities equipment and facilities capital and expense projects.  He/She is expected to contribute to the design, development and enhancement of all of the plant facilities and utilities and manage projects to replace, modernize and improve plant facilities as required to maintain the plant in peak condition and or support business growth. He/She will provide technical leadership that drives significant improvement in achieving Operational Excellence.  

 

This role is primarily responsible for the designing, engineering, and planning for all facilities and utilities projects related to modernization of existing pharmaceutical production facility, including new and retrofit projects to support production and plant operating activities. Provides technical advice on all facility and utility equipment purchases. Manages and resolves construction related problems as required. Coordinates activities of crafts supporting facility and utility projects both during and after project managing risks to product and personnel.

 

In addition this role, as an extension to the site's Process, Utilities and Facilities Teams, will be responsible for assisting with trouble shooting facility and utility systems on an as needed basis which includes but not limited to chillers, air handler units (AHUs), WFI loops, clean steam generators, vapor compression stills, etc. Provide investigation, engineering and change control support for all systems including investigation of deviations of facility and utility systems and the determination of the root cause, along with the development of corrective actions to prevent reoccurrence.

Responsibilities

  • Leadership of projects from initial project definition and scope development, schedule, budget, user and functional requirements, conceptual design, detailed design, risk assessment, and equipment selection through start-up, commissioning, and qualification.
  • Work with internal and external partners to develop, design and implement comprehensive cGMP facility, utility, environmental,EHS/OSHA, material and personnel workflow improvements to optimize manufacturing operations and ensure regulatory compliance.
  • Lead program of complex Capital Projects in a fast-paced, multi- disciplined, cross-functional team environment to ensure desired outcome is achieved. Manage all change orders, invoice approvals, reports, and change controls.
  • Develop and manage capital project schedules in order to meet overall program goals, including budget and timeline. Communicate status of project activities on a regular basis.
  • Lead internal and external design reviews to ensure timely execution of project plans.
  • Provide technical expertise and leadership in all facets of a project from project development, budgeting, and life cycle costing to project execution, completion, and reporting.
  • Work with the providing technical input as required ensuring technical requirements reflect desired outcomes.
  • Responsibilities include oversight of the design, development and integration of state-of-the-art equipment systems, accomplishing project objectives to cost, time, quality and compliance requirements.
  • Ensure successful equipment / systems delivery qualifications, integration and manufacturing validation.  Facilitate the   establishment of acceptance criteria for both pre- & post-delivery    equipment qualifications.  Work in conjunction with site operations     to develop Functional Requirements for manufacturing equipment. 
  • Lead and/or support investigations to troubleshoot, identify root cause, and resolve manufacturing issues.
  • Support the development and execution of an engineering strategy based on industry standards and best practices ensuring regulatory compliance through the selection and implementation of the latest technology in facility design, processing equipment and      methodologies.
  • Support process validation and documentation activities as necessary.
  • Evaluate and monitor the preparedness of manufacturing facilities for future regulatory inspections.  Support regulatory agency audits,CAPA investigations and closure plans.
  • Support facilities and manufacturing with training, documentation packages and preventative maintenance procedures.

Qualifications

BS or MS in Chemical or Mechanical Engineering preferred. Advanced Degree and Electrical or Controls experience are a plus.
• Minimum 10 years' experience, relevant technical and project leadership experience in an aseptic environment with a proven track record of delivering to objectives.
• Display a solid technical understanding of engineering principles and procedures and their application to the plant with demonstrated knowledge of HVAC, compressed air, steam, and water systems.
• Demonstrated technical expertise, operational understanding and cGMP compliance in aseptic operations.
• Familiarity with technology transfer, regulatory documentation and operations infrastructure.
• Familiarity with product and process change management and quality systems and with FDA regulated facilities and manufacturing audits.
• Demonstrated ability to write technical reports and to clearly and concisely present technical information to multi-disciplinary groups.
• Excellent computer skills, solid analytical skills, demonstrated excellent interpersonal, leadership and Project Management Skills.

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