Project Manager- GMP
Azzur Group
Summit, new jersey
Job Details
Full-time
Full Job Description
Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking a Senior Quality Validation Engineer who is passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!
Overview: As a Project Manager at Azzur Group, you'll take the lead in overseeing GMP projects, with a strong focus on effective communication, accountability, and mastery of project scope. Your key responsibilities will involve nurturing client relationships, mentoring team members, and implementing efficient processes.
Essential Duties and Responsibilities:
- Manage project deliverables from proposals, specifications, and meetings.
- Draft engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV).
- Validate manufacturing/laboratory equipment in regulated GMP environments.
- Execute commissioning and validation documentation in the field.
- Communicate with clients and build relationships throughout the project.
- Oversee core team performance, project schedules, and budget commitments.
- Lead project strategy definition, goal development, and scope management.
- Identify and communicate project risks, developing risk management plans.
- Anticipate and manage conflict situations for positive outcomes.
- Interact continuously with all organizational levels to ensure effective communication.
- Mentor and train junior engineers actively.
Requirements
Experience:
- 10 years in validation, qualification, or requalification of laboratory or manufacturing equipment in a GMP environment, with 5 years in project management.
Education:
- A bachelor’s degree in engineering or science is required.
- MS Project proficiency required.
- PMP certification desirable.
- PMI, IPMA, or equivalent certification preferred.
Benefits
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)