We at Azzur Group are looking for an experienced Mid Level CSV consultant to join our Azzur Consulting: Princeton team.
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!
- Lead, direct and develop company personnel through all technical aspects of the project lifecycle.
- Develop project plans, define roles and responsibilities and the scope of work for each project with input from key stakeholders
- Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means.
- Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV).
- Perform (hands on) field execution of commissioning and/or validation documentation.
- Responsible for working with all team members to ensure timely delivery of project requirements (schedule, budgets, and costs). Ensure project team members work within the project schedule and budgets. Provide updates to client and management indicating status of project as required.
- Perform business development work as necessary to procure additional work at their site as well as additional clients.
- Actively participate in the mentoring, training of junior engineers and development of internal company policies and procedures
- BS in Engineering, Science or equivalent technical degree.
- Minimum 4 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- MasterControl, Valgenesis, ProCal and LIMS knowledge