Principal Project Engineer

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Regular Full-Time Boulder, CO, US

9 days ago Requisition

Salary Range: $ To $ Annually

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

The Principal Project Engineer is responsible for managing and executing capital projects in support of pharmaceutical drug substance, intermediates, and fine chemical development and production. The Principal Project Engineer manages multiple, high value, complex, projects over a diverse number of disciplines including civil; mechanical; equipment and facilities design and installation; technology transfer; and product delivery. Ensuring project cost, schedule and quality control, and adherence to regulatory laws and practices throughout the project life cycles are central to this position.

Include the following. Other duties may be assigned.

• Takes a lead role in working with the project owner and supporting staff to develop the project business case and project objectives. Ensures relevant alternatives are evaluated and the recommended solution is supported by local staff and management. Generates and communicates (i.e., presentations) and effectively builds consensus for proposals with project stakeholders as well as management
• Plans, develops, coordinates, and directs the entire engineering effort for assigned projects, ensuring project success. Directs efforts relating to the generation of cost estimates and capital requests. Manages the purchasing & contracting activities to ensure timely, cost-effective equipment and services are provided for the overall project. Proactively demonstrates responsibility for ensuring that cost, scope, and schedule requirements are met
• Reviews project design for compliance with engineering principles, company standards, customer contract requirements, and related specifications. Leads the evaluation of the feasibility and soundness of proposed engineering designs and procedures. Performs as a staff advisor and consultant as to a technical specialty, a type of facility or equipment, or a program function (involving the integration of several business systems)
• Develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others. Secures resources for specific phases or aspects of projects such as technical studies, system design, preparation of specifications and technical plans, construction, and qualification
• Leads timely resolutions of disputes and conflict resolution with external contractors, vendors, and stakeholders
• Project activities include, but are not limited to, user requirement specification input and review; scope development; process design; funding request preparations; evaluation of equipment system standards and specifications; project controls; overseeing change control process, implementation logistics; resolving internal and external disputes; resolving engineering design and performance problems; construction supervision; building permits; and qualification and validation efforts
• Interacts with customers as “Technical Lead” for Project Engineering concerns
• Provides updates (formal and informal) to Production Management and LT, as needed, regarding project progress,…