Engineer II, Capital Projects

ElevateBio•Waltham, MA

5h•$125,000 - $165,000

About The Position

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Capital Project Engineer II is responsible for executing a project or group of tech transfer, capital projects from conceptualization to successful conclusion; accountable for defining the goals and intended outcomes of each project along with project scope, risk, procurement methodology, schedule, and budget. Lead the planning, design, and construction of the project using established processes, experience, and expertise while providing exceptional communication to all project stakeholders. You will lead/support aspects of the Capital Planning process, helping to establish and track against corporate business plan.

Requirements

Bachelor’s degree in engineering or another related field.
Experience working in GxP pharmaceutical and/or biotechnology regulated environment.
Experience in biologics and/or cell and gene therapy manufacturing equipment
A minimum of 6 years project or construction management experience, managing multiple complex capital projects.in the Biotechnology, Pharmaceutical or related industry
Strong operational knowledge of MEP / Process systems and controls.
Highly functional in a fast-paced dynamic company with the ability to prioritize issues under differing pressures and to work collaboratively with cross-functional teams.
Excellent written and verbal communication skills.
Deep understanding of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards
Experienced working on all aspects of capital projects, KPI’s, including budgeting, design, construction, validation, start-up, and ongoing operations.

Nice To Haves

Proficiency with SAP, Kneat, Smartsheet, Microsoft Project, Bluebeam Revu Project Systems preferred.

Responsibilities

Develops, plans, coordinates, and directs engineering aspects of projects of major scope and importance. Manages multiple, often concurrent projects and meets expectations. Understands the business needs and has a thorough knowledge of the customer when developing a project scope.
Incorporates business foresight of emerging technological trends. Leads development of Project Charter and documents the initial requirements that satisfy the stakeholders’ needs and expectations. Establishes engineering project objectives and technical criteria for evaluating project results and activities of the project team.
Oversee design, construction, commissioning, qualification (if applicable) and readiness workstreams for each assigned project. Provides technical input from experience and/or solves technical challenges with input from ElevateBio SME’s and stakeholders.
A Subject Matter Expert (SME) in project engineering. Participates in internal, cross-functional teams to develop and align procedures and standards.
Creates or coordinates the solutions for complex problems; integrates regulatory and operational needs; performs cost / benefit analysis. Explores multiple alternatives. Seeks input from cross functional teams in resolving major project hurdles. Resolves problems and crisis situations requiring fast, astute decisions with rapid implementation by utilizing technical training and /or experience.
Defines roles and responsibilities. Directs efforts of internal and external resources.
Perform tasks, such as writing Requests for Capital Expenditures (RCEs), safety / quality checklists, scope documents, etc.
Ensure safe implementation of capital projects by keeping safety first and foremost in project development and execution.
Use established PM tools and techniques (Cash Flow Projections, Scope / Schedule Control, etc.) to stay within authorized budget limits and achieve the overall project and organizational objectives. Contributes to the development of project management best practices. Directs and manages Project Execution by performing the work defined in the project plan to achieve project objectives.
Achieves effective financial control through management of project scope, estimating, effective use of SAP, budget control tools, risk management, and project closeout.
Monitors and controls project work to meet the performance objectives defined in the project plan. Focuses on cost and milestone achievement to optimize resource utilization. Reviews change requests, manages, and approves changes to the deliverables, organizational process assets, project documents, and the project plan.
Closes the project by finalizing all activities across all the Project Groups to formally complete the project or phase. Leading financial asset closure with finance.