Overview:
The purpose of this position is to plan, manage, and execute engineering and technical projects from initiation to commercialization. The size and scope of the projects assigned are large and complex, and usually consist of high-profile equipment and process implementations that support development and/or launch activities. The Sr. Project Engineer will own and lead the management of engineering capital related activities in a cGMP environment including planning, organizing, and controlling all elements of the project. Projects include but are not limited to cGMP manufacturing suite design and construction, facility utility and support systems, acquisition of filling and packaging equipment.

Candidate must have the ability to apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. Ability to work in a fast-pace environment and the competence to concurrently handle multiple projects and operational initiatives.

Responsibilities:
Plan, execute and evaluate projects according to predetermined timelines and budgets from awarding of business through commercial process validation.

Lead cross functional project teams, insuring quality control throughout project lifecycles.

Be accountable for project results.

Work with clients and other stakeholders to complete project charter outlining scope, goals, deliverables and required resources including budget and timing.

Provide project schedule to identify when each task will be performed.

Clearly communicate expectations and project updates to clients, team members and other stakeholders.

Resolve any issues and solve problems throughout project lifecycle.

Effectively manage project scope by ensuring any changes to scope are documented and approved by the client and internal team members.

Track and report on project milestones (both technical and business) and provide regular status reports.

Prepare project support documentation, including: project scopes, presentation of conceptual designs, capital requests, purchase orders, project plans and schedules using MS Project to drive successful project outcome, user/functional specifications, design specifications, piping and instrumentation diagrams, process flow diagrams, start-up and equipment operational procedures and commissioning.

Work with cross functional team and stakeholders to understand project requirements and provide expert guidance to ensure successful execution

Accountable for financial elements of projects, including contract review, financial milestone management, budget tracking and oversight, and will support invoice query resolution

Perform other duties and responsibilities as assigned.

Qualifications:
B.S. degree in an Engineering discipline preferably in Mechanical or Electrical Engineering is required with a minimum of 7 to 10 years of relevant experience in the pharmaceutical industry. PMP certification is a plus.

Must possess:
• Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization. Must strive for excellence in all aspects of job performance.

• Advanced knowledge of engineering documentation required for cGMP processing and substantial knowledge of cleanroom design and operation.
• Extensive knowledge of project management, utilizing PMO standards