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Posted: Tuesday, February 20, 2018 12:04 AM

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Company Name: Shire

Industry: Biopharmaceuticals/Biotechnology
Job Function: Engineering Support
Job Type: Full-Time
Job Duration: Indefinite
Min Education: BA/BS/Undergraduate
Min Experience: 7-10 Years
Required Travel: 0-10%

Job Description

Shire operates the Los Angeles plant which performs fractionation and purification of human plasma to safely produce quality therapies that save and sustain lives. The facility has evolved over the last six decades through expansions, upgrades and increases in output.  In order to maintain a reliable supply of therapies for patients, Shire manages projects to improve manufacturing and auxiliary processes on a continuous basis. These projects executed locally at the Los Angeles plant and globally throughout the Shire Technical Operations organization. 

The Sr. Project Manager for Reliability 360 Program is accountable for all business aspects of project performance relating to the Reliability 360 program initiative at the Los Angeles site.  Including:

  • Prioritization, planning and execution of project activities
  • Managing project resources and timelines to deliver results
  • Overseeing program performance and acting as liaison for senior management

Essential Duties and Responsibilities

  • Responsible for performance and oversight of program portfolio
  • Develop into Reliability 360 subject matter expert and guide teams to meet equipment reliability targets
  • Executing Reliability 360 risk assessments, equipment design review, SOP optimization and training needs assessments
  • Drives action completion that align with business needs and deliver results
  • Develops and implements strategy to achieve site objectives and production ramp-up targets
  • Provides clear direction on product/process development requirements and facility/equipment upgrades required to meet expectations of customers and stakeholders.
  • Leads the team in defining program strategies and goals, and assigns/manages project tasks to ensure the project team meets all commitments.
  • Sets the project strategy, schedule, aligns resources and provides ongoing analysis of financial and schedule performance.
  • Communicates program status updates to all levels of management.
  • Develops and manages team deliverables required for successful project completion
  • Provides technical support for all project phases; product/process development, project execution and transition into manufacturing.
  • Anticipates and resolves conflict situations to ensure win-win outcomes.
  • Must manage all project requirements including engineering design, equipment evaluation and procurement, contractor selection and coordination of all project resources to ensure successful project execution, validation and handover to manufacturing.
  • Must be willing to work evenings and weekends, as required, to oversee project activities.
  • Drives use of Shire's Project Management Methodology throughout Projects.
  • Demonstrates a commitment to continuous improvement
  • Coordinates activities cross functionally to meet target dates and program deliverables.

Job Requirements

Qualifications

  • Must be well versed in Project Management tools and must possess knowledge of related disciplines.
  • Must have knowledge of such principles as GMPs, FDA guidelines and purchasing practices.
  • Experience with commissioning and validation concepts, procedures, protocols and requirements to support GMP are required.
  • Must have proficient knowledge of process improvement methodologies and tools such as DMAIC.
  • Experience conducting Risk assessments such as FMEAs with cross functional teams is strongly preferred.
  • Is familiar with Quality Engineering, Reliability Engineering and/or Reliability Centered Maintenance (RCM) concepts.
  • Strong understanding of manufacturing equipment and design.
  • Strong understanding of manufacturing and training requirements
  • Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as, project management tools.
  • Ability to manage multiple cross-functional teams simultaneously.
  • Ability to design and implement projects/studies outside area of expertise.
  • Must demonstrate strategic leadership, strong financial acumen, and proficient supervisory skills.

Education and/or experience

  • Typically requires Bachelor’s degree preferably in science, engineering or other related technical field. 8+ years of related professional experience with 3+ years in management role.
  •  Experience in Engineering and Manufacturing preferred.
  • Experience in FDA regulated environment preferred
  • Professional certification(s) or certificate(s) in the area of process improvement methodologies is/are a plus (examples: CQE, CRE, SixSigma, CMRP etc.). 
  • A professional Project Management certification  is a plus (e.g. PMP)

Physical Demands

  • Must be able to lift, push, pull and carry up to 25 lbs.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

  • Normal office environment.
  • May be required to travel for business reasons. e.g. training and meetings.
  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • May work in a cold, wet environment.
  • May be around moving equipment and machinery.
  • May be required to work in a confined area.
  • Some clean room and cool/hot storage conditions.

Contact Person: Lala Aboulian
Phone: 8185074517
Email Address: lala.aboulian@shire.com

• Location: Los Angeles, Los Angeles, California

• Post ID: 159717182 la
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