Sr. CQV Consultant

Location: Washington DC Consulting
Department: Azzur Washington DC LLC

Job Description

We at Azzur Group are looking for a Sr. CQV Consultant to join our Azzur Consulting: DC team. 
Azzur personnel are expected to live up to our core values 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.

  • Development and editing of SOP
  • Development and execution of validation test procedures
  • Development of project plans, as app­ropriate
  • Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes
  • Technical presentations
  • Technical report writing
  • Data Analysis
  • P&ID walkdowns


Responsibilities:

Important: Critically think about a holistic approach to Facility, Utilities, and Process Engineering activities

  • Development of life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes.
  • Development of a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
  • Development of legacy procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
  • Provides client team members with basic understanding of regulatory and manufacturing requirements.
  • Ability to generate templates and legacy documents for life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes.
  • Development of a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
  • Development of legacy procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
  • Provides client team members with basic understanding of regulatory and manufacturing requirements

Qualifications

  • Must be willing to travel and work onsite as an essential worker supporting essential businesses
  • BS in Engineering, Science, or equivalent technical degree.
  • 10+ years’ experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Experience in writing and executing protocols including systems such as process validation, utilities, manufacturing equipment
  • Working knowledge of FDA and cGMP regulations and documentation practices
  • Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
  • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Proficient in Microsoft Word, Excel, and PowerPoint
  • Mathematical Skills, Computer Skills including Microsoft Word and Excel, Statistical analysis skills

Preferred Qualifications

  • Pharmaceutical experience, specifically biologics
  • Application of analytical and process validation a plus
  • Experience with temperature mapping
  • Basic knowledge of calibration
  • Basic knowledge of laboratory validation
  • Basic knowledge of computer system validation
  • Project management skills

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 Opportunities


Apply Now