Staff Engineer, Project Engineering

Thermo Fisher Scientific•Saint Louis, MO

7d•Onsite

About The Position

The Staff Engineer is part of the Engineering team at Thermo Fisher Scientific’s multi-product, multi-client biopharmaceutical site in St. Louis, which manufactures pharmaceutical products for (pre)clinical trials and commercial applications. The role manages and supports capital projects that enhance manufacturing capabilities and ensure compliance with Good Manufacturing Practice (GMP) standards. It reports to the Manager of Manufacturing Engineering. The position manages contractors and capital projects valued up to $5 million, oversees project scope, schedules, and budgets, and leads project start-up and commissioning. It also supports quality records and GMP documentation, ensures compliance with regulatory requirements and site safety standards, and coordinates with cross-functional teams, business leadership, customers, and regulators as needed.

Requirements

Bachelor’s degree or higher in Engineering (Chemical, Mechanical, Electrical, or Bio) and at least 5 years of experience; 8 or more years preferred, or an Associate degree and at least 8 years of related professional experience.
At least 5 years of pharmaceutical industry experience or experience in a similar industry.
Experience managing contractors and projects valued up to $5 million.
Experience authoring documents in a GMP setting.
Experience working in a cleanroom.
Prior experience with commissioning and validation in a pharmaceutical setting.
Knowledge of building codes and regulations.
Understanding of regulatory requirements for pharmaceutical facilities.
Excellent written and verbal communication skills.
Strong attention to detail.
Proficiency with Microsoft Excel, Word, Outlook, Project, and PowerPoint.
Proficiency with AutoCAD and Bluebeam.
Must be legally authorized to work in the United States now and in the future without sponsorship.
Must be able to pass a comprehensive background check, including drug screening.

Nice To Haves

Eight or more years of experience for candidates with a Bachelor’s degree or higher in Engineering.

Responsibilities

Manage contractors and capital projects valued up to $5 million.
Develop and track project scope, schedules, and budgets.
Initiate, manage, and close quality records related to capital projects.
Drive closure of intermediate quality-record tasks to support departmental compliance and timely completion.
Author and review GMP documents as needed to support capital project objectives.
Lead start-up and commissioning activities for capital projects.
Ensure capital projects comply with regulatory requirements, industry standards, and company policies.
Collaborate with MSAT, PD, Quality, Operations, and Maintenance teams to align projects with business objectives.
Conduct feasibility studies, prepare detailed project plans, and manage project timelines and budgets.
Perform risk assessments and develop mitigation strategies.
Engage business leadership as needed to obtain project approval and align deliverables with business objectives.
Engage customers and regulators as needed for managed projects and areas of expertise.
Drive adherence to site safety standards, including applicable assessments of new facilities and equipment.