Principal Project Engineer

Merck•Lenexa, KS

5d•Onsite

About The Position

As a Principal Project Engineer at the Lenexa, KS site, you will lead key projects related to the design, qualification, and optimization of the cell culture media manufacturing equipment and facilities to ensure safe, compliant, and scalable production of high-quality media for biopharmaceutical applications. This includes technical project management for both capital projects and process improvements. You will develop project scope and ensure seamless implementation of the most efficient, viable technical solution in alignment with internal standards. You will collaborate with process engineering, manufacturing, quality, EHS, and maintenance to ensure robust design, commissioning, qualification, and operational readiness. Additionally, you will drive project timing, budget, and risk management, and prepare and present status reports to leadership and stakeholders. You will ensure adherence to data integrity and change-control practices, owning the engineering change process, and you will mentor engineers and cross-functional teams to foster a culture of safety, quality, and continuous improvement. You will identify and implement cost-saving opportunities, technology upgrades, and energy/water efficiency improvements, and ensure facilities and equipment meet regulatory and MilliporeSigma corporate standards for cell culture media manufacturing operations.

Requirements

Bachelor’s degree in Chemical, Biochemical, Mechanical, or Biomedical Engineering (or a closely related field)
5+ years of professional engineering experience
Experience managing projects over $1M

Nice To Haves

Master’s degree preferred
Experience with validation strategies (IQ/OQ/PQ) and commissioning/qualification activities
Familiarity with automation concepts, sensors, control systems, data integrity, and change control.
Proven project management and leadership capabilities
Ability to influence across functions
Excellent problem-solving, risk assessment, and decision-making skills
Strong communication and technical writing abilities
Experience in medical, biotechnology, or Bio-pharmaceutical manufacturing environment is highly preferred
PMP certification preferred

Responsibilities

Lead key projects related to the design, qualification, and optimization of cell culture media manufacturing equipment and facilities.
Ensure safe, compliant, and scalable production of high-quality media for biopharmaceutical applications.
Provide technical project management for capital projects and process improvements.
Develop project scope and ensure seamless implementation of efficient, viable technical solutions.
Collaborate with process engineering, manufacturing, quality, EHS, and maintenance for design, commissioning, qualification, and operational readiness.
Drive project timing, budget, and risk management.
Prepare and present status reports to leadership and stakeholders.
Ensure adherence to data integrity and change-control practices, owning the engineering change process.
Mentor engineers and cross-functional teams.
Identify and implement cost-saving opportunities, technology upgrades, and energy/water efficiency improvements.
Ensure facilities and equipment meet regulatory and MilliporeSigma corporate standards.