Project Engineer
Description
Project Engineer Job Description:
We are seeking a highly motivated and experienced Project Engineer to join our team. In this role, you will be responsible for engineering projects within the Life Sciences industry, including pharmaceutical manufacturing facilities, laboratory environments, and medical device production sites. You will collaborate closely with clients, internal teams, and external vendors to ensure project success from inception to completion. Your expertise in engineering principles, regulatory compliance, and project management will be instrumental in driving operational excellence and delivering superior results.
Responsibilities/Expectations:
- Execute engineering projects in the Life Sciences industry, ensuring adherence to project timelines, budgetary constraints, and quality standards.
- Collaborate with clients to define project goals, requirements, and specifications, ensuring alignment with industry regulations and best practices.
- Generate lifecycle documentation including design specifications (URS, FDS, DS).
- Develop and execute test documentations such as FATs, SATs, Commissioning Protocols,
- Qualification/Validation Protocols.
- Summarize execution activities in final reports.
- Draft SOPs for operation, maintenance and calibration of equipment, utilities and facilities.
- Coordination of construction with EHS to ensure safety of personnel.
- Work with vendors, stakeholders and contractors to incorporate assets into the client’s asset management system.
- Contribute to project execution meetings, forecasting including input from contractors, and status execution updates.
- Coordinate Commissioning and Qualification of Facilities, Utilities and Equipment.
Qualifications:
- Education: BS/BA degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering.
- Working knowledge of FDA/EU regulations and requirements for biologics and pharmaceuticals in a project engineering role.
- 4+ 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.
- 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.
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!