DescriptionDo What You LoveAt 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/resultsUnderstands the competitive landscape of the medical device, pharmaceutical, and biotechnology industryWilling to work hands on, assist with building client libraries, learn from a mentor and become a mentor for othersUnderstands worldwide regulations and phase appropriate applicationsDraws insights from projects and supplemental research to help drive new and existing growthEnsures activities are efficient, optimized, and client-centricHighly motivated and organized, solutions oriented leaderCurious and adaptable
– has the ability to transform knowledge into actionable activitiesAble to produce results in a fast paced, collaborative environment Essential Duties and ResponsibilitiesAzzur 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.Lead, direct and develop company personnel through all technical aspects of the project lifecycleDevelop project plans, define roles and responsibilities and the scope of work for each project with input from key stakeholdersUnderstand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other meansWrite engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV)Perform (hands on) field execution of commissioning and/or validation documentationResponsible 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 requiredPerform business development work as necessary to procure additional work at their site as well as additional clientsActively participate in the mentoring, training of junior engineers and development of internal company policies and proceduresQualificationsBS Engineering or related discipline3-5 years’ project management experience in the pharmaceutical and/or biotechnology industry is requiredMicrosoft Project Experience is requiredExperience with FDA compliance and cGMP is requiredMust be results oriented with several years of hands-on experience, familiar with industry concepts, practices and procedures in a cGMP environmentExperience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.)Demonstrated experience managing others as well as fostering a team focused approach.
The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative and business integrityExcellent verbal, oral, and technical writing communication skillsProficient in Microsoft Word, Excel, Power Point and able to quickly learn new computer applications