Validation Engineer (Consultant)

Location: San Francisco Bay Area

Job Description

About Azzur
Azzur West is a GxP consulting organization dedicated to providing high quality, expertly backed assistance that drives pharmaceutical, biotechnology and medical device companies to success. We are seeking highly motivated and talented individuals to join our incredible team.

Our purpose and passion is to “Foster a culture that attracts and enables individuals with unique abilities and passions to reach their life and career goals.” We look for talented individuals who take pride in the work they do. We fuel employee growth by encouraging our employees to focus on doing what they love and what they do best. Qualified candidates must have a desire to learn, apply, engage and adapt while simultaneously exuding Azzur’s

Core Values: Put Others First, Courage to Take Action, Take Personal Responsibility, Do What’s Right, and Have Fun!

Summary
The Regional Director will be reporting to the General Manager of Azzur West. He/She will be responsible for ensuring that day-to-day management needs of both Azzur and its’ clients are met by providing hands on support for projects, and direction for the team of consultants. The Director will also be responsible for growing the core consulting practice, managing & developing the team of consultants and executing billable consulting work as needed.


Ideal Qualities

  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Able to produce results in a fast paced, collaborative and client-centric environment
  • Draw insights from projects and supplemental research to help drive new and existing growth
  • Highly motivated and organized, solutions oriented leader
  • Highly effective interpersonal and project management skills to facilitate and influence diverse staff and management at all levels
  • Curious and adaptable - has the ability to transform knowledge into actionable activities that help grow the consulting practice while supporting and improving the existing systems and business


Essential Duties and Responsibilities

  • Practice, promote and develop Azzur’s purpose, passion and core values
  • Manage and oversee all aspects of the day-to-day operations of the project teams and opportunities located in the region
  • Ensure that all projects, initiatives and processes are in conformance with both Azzur & its clients’ requirements
  • Work closely with the General Manager and other Directors to develop company goals and identify new business initiatives
  • Closely monitor and report status of projects & key performance indicators
  • Maintain resource status updates and manage resource allocation for multiple projects & client sites
  • Create and support career development programs for individuals and conduct performance reviews
  • Support talent acquisition in the region including candidate interviewing, onboarding and mentoring
  • Attend client meetings, industry events, conferences, and other functions with key clients, partners and Azzur
  • Leverage industry knowledge and continuously expand professional networks to support business development efforts
  • Understand the landscape of the medical device, pharmaceutical, and biotechnology industry and identify growth opportunities for Azzur


Qualifications

  • Bachelor’s or Master’s Degree – Engineering/Technology/Lifesciences
  • 5+ years of engineering/technical project management within the biotechnology, pharmaceutical or medical device industries
  • 3+ years of demonstrated track record of success in consulting, general management and business development preferred
  • Proficient MS Office Skills – emphasis on Project, PowerPoint, Excel and Visio
  • Experience with implementing and managing business and resource management systems
  • Travel required: 20%
  • Working knowledge and experience with:
    • Project Management
      • Critical Systems / Facilities
      • Control Systems (PLC/SLC)
      • Water Pretreatment (RO/DI)
      • WFI (Generation/Distribution)
      • Compressed Gases (CA/N2/Vac)
      • HVAC / Clean Rooms
      • BMS / BAS / SCADA
      • Steam (Pure/Clean/Plant)
      • Emergency Generator / UPS
      • Stability Chambers
      • Filling (Vial/Syringe/Bag/Bottle)
      • Lyophilization
      • Packaging
      • Centrifuges
      • Filter Presses
      • UF / DF / NF
      • Washers (Vial/Stopper/External)
      • Autoclaves / Sterilization Pasteurization
      • Dry Heat / Depyrogenation
      • Refrigerators / Freezers
      • UV Tunnels
      • Process Tanks (Mixing)
      • Anaerobic Chambers
      • Capping Machines
      • Container / Closure
      • Printers / Labelers
      • Fermenters
      • CIP / COP / SIP Systems
      • Chromatography Separation
    • Process Engineering
      • Energy Efficiency
      • Process Optimization
      • Waste Elimination
      • Value Stream Mapping
      • Pull Systems
      • Kanban
      • Debottlenecking
      • Statistical Process Control
      • Standard Work
      • DMAIC
      • Risk Analysis (FMEA/HAZOP)
      • Kaizen Facilitation
      • Overall Equipment Effectiveness
      • Setup Reduction
      • Measurement System Analysis
      • Defect Reduction
      • Process Mapping
      • Design of Experiments
    • Quality Systems
      • Change Control
      • Regulatory Compliance
      • Nonconformances / Deviations
      • CAPA
      • Documentation Control
      • Shutdown / Startup
      • Facility Remediation
      • Training
      • Release
      • Internal / External Audit (SQA)
      • Laboratory Operations
      • Design Control
      • Requalification
      • Maintenance / Metrology
      • Management Review
    • Validation
      • Master Validation Plan
      • User Requirement Specification
      • Functional Specification
      • Design Specification
      • Engineering Specifications
      • Startup/Commissioning
      • Risk Assessment
      • FAT/SAT
      • Computerized System Validation
      • Process Validation
      • Cleaning Validation
      • Shipping Validation\Critical System/Utilities Validation
      • Equipment / Facilities (IQ/OQ/PQ)
      • Analytical Methods Validation
      • Material Qualification
      • Temperature Mapping
      • Traceability Matrices