Project Engineer, Quality Engineering

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.

SUMMARY

The Project Engineer is responsible for managing and executing capital projects in support of pharmaceutical drug substance, intermediates and fine chemical development and production. The project engineer manages multiple, high-value projects over a diverse number of disciplines including civil; mechanical; equipment & facilities design & 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.

Major and complex tasks will be performed with supervisory oversight.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

* Works with the project owner and supporting staff to develop the project business case and project objectives. Helps with the development of relevant alternatives; and supports their evaluation and that the recommended solutions are supported by local staff and management. Helps generate and communicate (i.e., presentations) and effectively build consensus for proposals with project stakeholders, as well as management

* Plans, develops, and coordinates engineering efforts, with supervisory oversight, for projects while ensuring project success. Supports efforts relating to the generation of cost estimates, as well as cost and schedule tracking. 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. Supports the evaluation of the feasibility and soundness of proposed engineering designs and procedures

* Supports evaluation of plans and criteria for a variety of projects and activities to be carried out by others. Helps to secure resources for specific phases or aspects of projects, such as technical studies, system design, preparation of specifications and technical plans, construction, and qualification

* Oversees project qualifications, including operational performance; and ensures the delivery of the specified project performance

* Project activities include, but are not limited to: user requirement specification input and review; scope development; supporting process design concepts; funding request preparations; evaluation of equipment system standards and specifications; project controls; overseeing change control process; implementation logistics; assisting in resolution of internal and external disputes; assisting in resolving engineering design and performance problems; construction supervision; building permits; and qualification and validation efforts.

LEADERSHIP & BUDGET RESPONSIBILITIES

This position is responsible for supporting assigned projects and for developing scopes, justifications, cost budgets, personnel requirements, and timelines for ensuring that all major project objectives are met. Provides direction to contract engineers. Fosters a project team atmosphere that facilitates positive employee morale. Willingness to take on significant challenges and difficult assignments without the promise of special rewards or recognition.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and…