Overview

The Principle Engineer - Technical Project Lead is responsible for managing strategic / technical engineering projects in a cGMP environment through planning, organizing, and controlling all elements of the project. Have the ability and competency to oversee all facets of the projects, inclusive but not limited to URS development, equipment procurement, installation, qualification and financial oversight. 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-paced environment and the competence to concurrently handle multiple projects and operational initiatives. This position is exempt from overtime.

Responsibilities

• Manage small, medium, and large projects from requirement specifications & design to implementation and validation phases as subject matter expert with minimal supervision.• Plan, execute and evaluate projects according to predetermined timelines and budgets from awarding of business through commercial process validation.• Lead cross functional project teams, ensuring 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.• Clearly communicate expectations and project updates to clients, team members and other stakeholders, while driving accountability• Resolve any complex issues and solve difficult problems throughout project lifecycle.• Prepare project support documentation, including: project scopes, presentation of conceptual designs, capital requests, purchase orders, project plans and schedules, user/functional specifications and design specifications.• Perform/Assist in the design review, factory acceptance, site acceptance, installation of equipment, as well as equipment qualification.• Evaluate equipment performance and provide improvement recommendations for equipment optimization, while ensuring safe operation.• Support compliance activities, such as change control, deviation management, investigations and CAPA resolution• Assist in writing and modifying procedures for the proper operation of new and/or existing equipment.• Assist in equipment transition from validation to commercial/developmental line use.• Assist the Business Development Team in closing new business.• Assist the Project Management Team in onboarding and launching new products• Identify and lead efforts to improve processes/systems.• Possibly delegate work, supervising, reviewing and developing lower-level personnel and/or staff.• Self-develop to be able to move into positions of greater responsibility as opportunities occur.• Perform other duties and responsibilities as assigned.

Qualifications

B.S. degree is required preferably in an engineering discipline with a minimum of 8-10 years of relevant experience in the pharmaceutical industry. PMP certification is a plus.