Department: Azzur of CA, LLC
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.
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!
Reports to the Engineering Director, executes and assists with management of customer corporate CAPEX and site specific OPEX projects of medium to high complexity, ensuring on-time and on-execution of projects. This includes:
- Execute projects per standard project management methodologies using a phased gate approach.
- Using Microsoft Project or other approved scheduling tools, develop and manage the project schedule and resolve conflicts.
- Facilitate project execution meetings, develop forecasting tools including input from contractors, and status execution updates.
- Provide project status reports to senior leadership using pre-approved formats and applicable software solutions.
- Manage project financials including the generation of purchase orders and tracking the associated invoices and work completion.
- Serve as the Engineering Subject Matter Expert (SME) during the planning, conceptual design and detailed design phases of a the project.
- Generate design specifications (URS, FS, DS).
- Draft and execute change control documents
- Participate in FATs and SATs and coordinate with Quality to approve Qualification relevant documents.
- Review construction drawings and specifications including PFDs, P&IDs, architectural, mechanical and electrical drawings to ensure adherence with approved design specifications and basis of design.
- Draft SOPs for operation, maintenance and calibration of equipment, utilities and facilities.
- Draft and execute commissioning test protocols.
- Support Failure Modes and Effects Analysis (FMEAs) on equipment and utility systems to identify and address high-risk failure modes to ensure adequate maintenance and reliability during operate and maintain phase.
- Resolve scope changes with Engineering, site Quality (when applicable) and construction groups.
- Coordinate the specification and procurement of major equipment purchases as well as the associated contractor agreements.
- Coordinate with the Environmental Health and Safety group to ensure safety of personnel during project execution.
- Works with vendors, stakeholders and contractors to incorporate assets into the client’s asset management system.
- Assists stakeholders with construction packages including format and content.
- Manage Requests for information (RFIs) to meet Qualification requirements.
- Coordinate Commissioning and Qualification of Facilities, Utilities and Equipment including resolution of deviations.
- Education: BS/BA degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus
- Working knowledge of FDA/EU regulations and requirements for biologics and pharmaceuticals in a project engineering role
- 5-10 years of project engineering or project management experience in pharmaceutical/biotech
- Strong knowledge of tools including schedules, communication plans, risk plans, resource plans, scope & change management tools, action item trackers, and project plans
- Knowledge of MS Project or Primavera as a tool to create integrated timelines and monitor project progress
- Excellent facilitation, negotiation, conflict resolution skills, and cross functional collaboration skills to foster positive business relationships with the ability to network with different functional areas.
- Excellent interpersonal, verbal and written communication skills in a collaborative work environment
- Follow-up on action items between team meetings and ensure accountability of team members
- Work with the Director, functional management, and governance teams to resolve conflicts and issues with projects and ensure alignment throughout the organization
- Understand and translate requestor’s strategies into plans, and be able to drive the project to completion
- Apply expertise as a project engineer within the biotech/pharma industry to successfully deliver project and programs while managing stakeholder expectations
- Effectively frame and present information to senior leadership
- Professional Engineering Certification is a plus
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ