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Project Manager

VTI Life Sciences (VTI) is a highly successful and growing Biopharmaceutical consulting company.  We are currently seeking a C&Q Project Manager to assist operations and work with our clients in the Greater Boston, MA area.

The C&Q Project Manager will be responsible for coordinating and developing project plans and project budgets and provides direct input into critical path issues and solutions, resource management, and project management from conception through the project life cycle. The C&Q Project Manager also collaborates with the Regional Director to assure integration of the project, company, and functional goals to achieve project milestones and timetables. He/she will support the overall project team and project leads in their strategic function. Must have a strong understanding of industry commissioning and qualification concepts and practices as well customer service.

VTI strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics, Medical Devices and Life Science industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment.  We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

Responsibilities:

  • Support conceptual / detailed design, construction / commissioning, and operational start-up activities from a validation perspective
  • Strong experience in Commissioning, Qualification, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics, Medical Devices and Life Scienc Industries.
  • Create validation strategy to confirm with industry best practices and to leverage existing documentation, determine family approach and grouping strategies
  • Identifies, negotiates and procures all project-related items, including third-party solutions
  • Plans, lays out and directs the work of functional reports
  • Drives and facilitates the project team to successful completion within budget and on schedule 
  • Provides guidance to project teams on implementation methodologies and internal project processes
  • Develops, maintains and reports project progress metrics
  • Prepares complex reports, project summaries and correspondence and ensures that all project work is properly and appropriately documented
  • Communicates issues and program/project status clearly and in a timely manner
  • Works collaboratively with Regional Managers to plan and coordinate projects and programs that support implementation processes, procedures, applications and technologies
  • Reads, analyzes and interprets professional documents, technical procedure, or governmental regulations
  • Mentors, trains and supports fellow project team members
  • Develops detailed project plans, baseline schedules, estimates, specifications, and budgets to achieve project objectives
  • Develop Validation Master Plan (VMP) and associated documentation as directed by clients

Qualifications:

  • BS or MS degree in engineering or science
  • 7+ years of relevant industry experience
  • Previous project management experience required
  • Project Management certification is a plus
  • Relevant technical expertise in cGMP operations
  • Proven track record participating in and leading projects for the biopharmaceutical industry
  • Strong team leadership ability 
  • Understanding of strong customer services
  • Strong verbal and written communication, interpersonal and negotiation skills
  • Excellent organizational and project management skills 
  • Familiarity with the following standards:

              - U.S. current Good Manufacturing Practices
              - Quality Management (ISO 13485)
              - Risk Management (ISO 14971)

  • Functional knowledge of Microsoft Office program, i.e. Word, Excel, Visio / Project Management Software

VTI Life Sciences Offers:

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our U.S. and global offices.  We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees as well as competitive hourly pay for our contractors. www.validation.org

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