Principal Project Engineer

Primary Duties

Develop, evaluate, and implement engineering solutions to highly complex problems. Role is accountable for all phases and project lifecycle requirements including but not limited to developing and controlling project business case justification, scope, budget, schedule, quality, risk, procurement, resources, project information, and communications. Typically, these are complex projects which exceed $10M. Support site strategy and objectives by successfully executing projects to ensure timely supply of products to patients and value to our shareholders. Role will primarily serve as Project manager, but may also serve as Engineering Lead for smaller, simple projects. For large, complex project's role is expected to serve as Project Manager only. Responsible managing and executing multiple, simultaneous high-quality projects on time and budget.

Responsibilities

• Responsible for the successful execution of both CAPEX and OPEX projects.
• Lead and direct cross-functional project teams with multiple workstreams.
• Serve as project manager and/or Engineering Lead on projects which may exceed $10M.
• Develop, evaluate, and implement engineering solutions to complex problems.
• Lead project team responsible for technical engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications.
• Drive the development and improvement of site project procedures, tools, and templates (Organizational Process Assets).
• Provide technical and project management mentoring to less experienced engineers.
• Support developing and tracking of department and site CAPEX metrics.
• Work under limited supervision, independently planning and prioritizing work.
• May provide day to day work direction to contingent workers and mentor lower level engineers.
• Complete mandatory training within required timeframe.
• Perform other duties as assigned.

Education and Experience

• Bachelor of Science degree in Engineering or related field.
• 7+ years as an engineer or technical project manager.
• Preferred Licensure- Engineer in Training (EIT) or Professional Engineer (PE)
• Preferred Licensure- Project Management Professional (PMP)
• Direct experience with the validation, operation, support, and/or design of cGMP manufacturing systems such as bioreactors, centrifugation, chromatography, filtration, Clean-in-Place, clean utilities, HVAC, electrical, and/or automated systems.
• Experience leading and directing cross-functional project teams of more than 10 project team members.
• Experience developing cost estimates, budget control, project scope definition, task/team supervision, procurement, project closeout, and all aspects of capital project execution.

Key Skills, Abilities, and Competencies

• Record of success in leading capital projects as project manager or discipline lead with experience in Technology Transfers.
• Individual must be capable of performing assignments that have loosely defined objectives and turn objectives into actionable deliverables.
• Proficient in the application of project management methodologies.
• Ability to organize and present technical communications without assistance.
• Proficient computer skills and be experienced using MS Office software (Word, Excel, and PowerPoint) and MS Project.
• Ability to work in a fast-paced, team-oriented, cross-functional environment.
• Ability to direct and manage multiple project teams of high complexity.

Complexity and Problem Solving

The complexity, scope, and scale of this role primarily entails transformational, novel, and advanced levels of systems, concepts, analysis, tools, and projects, as detailed in the 'Responsibilities' and 'Qualifications - Key Skills, Abilities & Competencies' sections. This position is intended for engineers with extensive industry experience, capable of navigating such complexities with independence, precision, and agility. Additionally, the role involves managing the cultural and cross-organizational dynamics inherent in implementing disruptive innovations and technologies.

Internal and External Contacts

In the role of Principal Project Engineer, you will engage with both internal and external stakeholders such as A&E, Construction, and Validation firms. Effective communication, collaboration, and networking are essential for success and professional growth.

Other Job Requirements

Physical Demands: In general, the position requires a combination of sedentary work and working throughout a manufacturing facility. May occasionally climb ladders. May be required to lift up to 25lbs.

Other / Travel Requirements: May require occasional off-shift or weekend hours to support project execution. May occasionally be required to wear personal protective equipment (PPE) and other clean room garments. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, booties, hair nets and gloves and hearing protection. Removal of makeup and jewelry would also be required at times. Infrequent travel but may approach 25-50% during project activities.