CQV Facilities Project Manager

Company: Azzur Group
Location: San Diego
Posted on: February 22, 2021

Job Description:

DescriptionAbout 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 LoveAt Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals. We take crucial steps to ensure that each employee is fulfilled both in and out of the office.In addition to our purpose, 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.--Essential Duties and ResponsibilitiesAzzur 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.

• Leads projects related to CQV, process engineering or process development
• Writes procedures, investigations, protocols, reports change controls, etc. for cleaning, shipping, facilities, utilities, systems, equipment and processes.
• Generates and executes life cycle documentation (Plans, URS, FRS, FAT, SAT, Protocols, Reports) for facilities, utilities, systems, equipment, cleaning, shipping and/or processes.Qualifications
  
  • Bachelors Degree in engineering, science, or equivalent technical degree or--Masters Degree in engineering, science, or equivalent technical degree
  • PMP Certification
  • 15+ years' experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Demonstrated Project management experience for facilities projects.
  • Experience in developing and executing validation lifecycle documents for facilities and related systems. (e.g. EMS, BAS
  • Experience using quality systems including deviation/investigation, CAPA and change controlPreferred Qualifications/Knowledge
    • Cell and Gene Therapy facilities and equipment validation experience
    • Control systems experience (e.g PLC, MCS, BAS/BMS)
    • Experience in manufacturing process development and tech transfer
    • Experience in risk management techniques (e.g. FMEA, HAZOP, FTA)
    • Strong knowledge of FDA and cGMP regulations and documentation practices
    • Strong knowledge of facility and control systems
    • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
    • Ability to read and interpret construction drawings, Piping and Instrument Diagrams (P&IDs), and electrical diagrams
    • Knowledge of key principles of ICH Q10
    • Basic knowledge of ISO 13485
    • Knowledge of manufacturing processes (e.g. upstream manufacturing, downstream manufacturing, formulation, aseptic filling, tableting, packaging and labeling)Perks of Working at Azzur
      • Medical, Dental and Vision
      • Competitive 401K plan
      • Volunteer Paid Time Off
      • Flexible Paid Vacation Time
      • Employee Recognition Program
      • Diversity and Inclusion Initiatives
      • Training and Mentorship OpportunitiesFind us on social media--Instagram for our California regions: Azzur_LA, Azzur_SD and Azzur_SFView our culture video in Youtube:https://www.youtube.com/watch?v=GPNjmsDu0LY
        
        
        
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Keywords: Azzur Group, San Diego , CQV Facilities Project Manager, Executive , San Diego, California