Project Manager

Location: Waltham, MA
Department: Azzur of NE, LLC

Job Description

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

  • Lead, direct and develop company personnel through all technical aspects of the project lifecycle
  • Develop project plans, define roles and responsibilities and the scope of work for each project with input from key stakeholders
  • Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means
  • Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV)
  • Perform (hands on) field execution of commissioning and/or validation documentation
  • Responsible for working with all team members to ensure timely delivery of project requirements (schedule, budgets, and costs). Ensure project team members work within the project schedule and budgets. Provide updates to client and management indicating status of project as required
  • Perform business development work as necessary to procure additional work at their site as well as additional clients
  • Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures

Qualifications

  • BS Engineering or related discipline
  • Minimum 7 years’ project management experience in the pharmaceutical and/or biotechnology industry is required
  • Experience with FDA compliance and cGMP is required
  • Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices and procedures in a cGMP environment
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.)
  • Demonstrated experience managing others as well as fostering a team focused approach. The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative and business integrity
  • Excellent verbal, oral, and technical writing communication skills
  • Proficient in Microsoft Word, Excel, Power Point and able to quickly learn new computer applications

Who we are:

Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:

  • Put Others First,
  • Have the Courage to Take Action,
  • Take Personal Responsibility, and
  • Have Fun!

Azzur can offer you:

  • Flexible PTO Policy
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

 



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