Senior CQV Consultant

Consulting Boston, Massachusetts Waltham, MA, Massachusetts


Description

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, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

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 Azzur’s core values:

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

Ideal Qualities:

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 medical device, pharmaceutical, and biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
  • 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
  • Curious and adaptable - has the ability to transform knowledge into actionable activities
  • 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.

  • Generate and execute life cycle documentation (FAT, SAT, CTP, DQ, IOQ, PQ) for facilities, utilities, manufacturing/QC lab equipment (cell culture, protein purification, cell and gene therapy, fill-finish) computer systems, automation and processes (cleaning, sterilization, shipping)  for qualification/requalification. 
  • Review, advise on and contribute to change control documents. Provides sound validation/verification assessments.
  • Write, review and revise a variety of Commissioning and Qualification protocol related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design review, or other technical documents such as  user requirement specifications (URS), system classification, system risk assessments, 21 CFR Part 11 compliance assessment, functional requirement specifications (FRS), detailed design specifications, and/or commissioning test procedures.
  • Writes summary reports to summarize Commissioning and Qualification testing.
  • Writes procedures, investigations, change controls, etc. to support the validation lifecycle documentation. 
  • Develops and executes validation plans and protocols for Process Performance Qualification (PPQ), mixing validation, L&E, materials qualification and other manufacturing processes.
  • Work with contractors and equipment vendors, as necessary, to ensure validation packages are provided and completed to the required standards, on schedule.
  • Performs P&ID Walkdowns, installation and operational tests for equipment and utilities. Performs Thermal mapping of temperature controlled chambers, (refrigerator, freezers, incubators, cryo storage) warehouses, and SIP processes
  • Initiates and performs investigations to close out protocol discrepancies and deviations. Ensures corrective actions are resolved in a timely manner. Supports the resolution of regulatory observations or manufacturing site issues.
  • Provides assistance with project management for mid to complex size projects for commissioning, qualification of new engineering systems and facilities.
  • Work independently to collect, organize and evaluate validation data and review work of other engineers in the team. Keep validation management informed about the progress and any obstacles.
  • Collaborate well with the cross-functional team and work efficiently in a team environment. Communicate effectively with management, stakeholders, regulatory agencies and vendors. Assists in providing training to other engineers in the team.
Requirements:
  • 5+ years’ experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, cell and gene or medical device industry
  • Hands on experience in executing C&Q protocols for facilities, utilities and manufacturing/ QC lab equipment and processes.
  • Experience in Quality or QAV is desired.
  • Strong knowledge of FDA, EU and cGMP regulations and good documentation practices
  • Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
  • Proficient in Microsoft Word, Excel, Project and PowerPoint