Sr. Validation Project Manager

Location: Raleigh Consulting
Department: Azzur of North Carolina, LLC

Job Description

Candidate must have:

- Strong Microsoft Project skills
- Strong communication skills
- experience with commissioning and validation of utilities, lab instruments and manufacturing equipment in the biopharm industry
(types of utilities, equipment: WFI, gas, vacuum, steam, autoclaves, bioreactors, air samplers, biosafety cabinets, HPLC, etc.)
- attention to detail



Ideal candidates will exhibit, or have the willingness to develop, the following qualities:


  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Understands the competitive landscape of the pharmaceutical, and biotechnology industry 
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing growth. 
  • Ensures activities are efficient, optimized, and client-centric. 
  • Highly motivated and organized, solutions oriented leader
  • PMP Preferred
  • Able to produce results in a fast paced, collaborative environment   

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
  • 10+ 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

About Azzur:

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.


Do What You Love

At Azzur Group, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 5 core values; Integrity, Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun. 

It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.

We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.

If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.



Apply Now