Project Manager - CQV

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzurs core values:

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

Responsibilities:

• Writes procedures, investigations, protocols, reports, change

  controls, etc. to support the Maintenance and Engineering, Validation,

  Quality, and Regulatory departments.

• Generates validation life cycle documentation (FAT, SAT, IOQ,

  PQ) for cleaning, sterilization, shipping, and processes validation and

  facilities, utilities, systems, equipment qualification/requalification.

• Writes and revises 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 test plans, engineering design reviews,

  commissioning, qualification or other technical documents, user

  requirement specifications (URS), functional requirement specifications

  (FRS), detailed design specifications, factory acceptance test documents

  (FAT), and/or commissioning test procedures.

• Performs on site or support work for a client under supervision, including

  but not limited to:

  • Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal

    mapping of temperature controlled chambers, warehouses, and

    sterilization processes

  • Equipment Qualification test execution
  • Investigations and deviations
  • Risk analysis, and/or
  • Data integrity assessments and review of client data
• Executes protocols and helps resolve deviations/discrepancies,

  analyze study data and write summary reports, under supervision of

  senior consultants.

Qualifications and Experience:

• Bachelors Degree in engineering, science, or similar field or equivalent experience; Preferred Education: Masters Degree in engineering, science, or similar field
• 2-8 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
• Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation
• Experience with temperature mapping
• Experience with many aspects of validation
• Working knowledge of FDA and cGMP regulations and documentation practice
• Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams