Job Description

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! JOB DESCRIPTION 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:

• Generation of design specifications (URS, FS, DS)
• Draft and execute change control documents
• Execute FATs and SATs
• Proficient with reviewing and understanding construction drawings including PFDs, P&IDs, architectural, mechanical and electrical drawings
• Draft SOPs for operation, maintenance and calibration of equipment, utilities and facilities
• Draft and execute commissioning test protocols
• Serve as the Engineering Subject Matter Expert (SME) during the planning, conceptual design, basic design, and detailed design phases of a project
• 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
• Resolving scope changes with engineering, site quality (when applicable) and construction
• Working with procurement on equipment purchases as well as contractor agreements
• Coordination of construction with EHS to ensure safety of personnel
• 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
• Requests for information to meet qualification requirements
• Project execution meetings, forecasting including input from contractors, and status execution updates
• Support Validation execution in an Engineering Subject Matter Expert (SME) role, including resolution of deviations
• Coordinates Commissioning and Qualification of Facilities, Utilities and Equipment
• Assists the director with business process and program improvements
• Willingness to learn and expand comfort zone
• Cross functional projects
• Corporate strategy, manufacturing site specific, or R&D type projects
• Process Improvements

QUALIFICATIONS 

• 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 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
• Proficient with using Autocad

Company Description

Azzur is a GxP consulting organization dedicated to providing high quality, expertly backed assistance that drives Pharmaceutical, Biotechnology and Medical Device companies to success. We are seeking highly motivated and talented individuals to join our incredible team.