Project Engineer, Manufacturing Engineer

Job Title:

Project Engineer

Job Description

The Project Engineer will plan, execute, and oversee engineering projects within a manufacturing facility to improve efficiency, productivity, and regulatory compliance. This role collaborates closely with production, quality, maintenance, and other departments to ensure projects are delivered on time, within budget, and aligned with operational needs. The Project Engineer applies strong technical expertise to solve complex problems, optimize processes, and drive continuous improvement across manufacturing operations.

Responsibilities

+ Develop detailed project plans that clearly define scope, objectives, timelines, and budgets.

+ Coordinate and manage engineering projects from conception through completion, ensuring they meet defined goals and performance targets.

+ Conduct feasibility studies and risk assessments to evaluate proposed projects and recommend appropriate solutions.

+ Provide technical support in the design, installation, and commissioning of equipment and systems within the manufacturing facility.

+ Develop engineering solutions to improve manufacturing processes, reduce operational costs, and enhance product quality.

+ Ensure all engineering activities comply with GMP, FDA, and other applicable regulatory standards.

+ Collaborate closely with production, quality assurance, maintenance, and other functions to align projects with operational requirements.

+ Facilitate effective communication among project stakeholders by providing regular updates on project status, risks, and progress.

+ Lead or actively participate in cross-functional teams to support continuous improvement initiatives.

+ Prepare and maintain comprehensive project documentation, including plans, reports, records, and technical files.

+ Ensure all project activities are fully documented and comply with regulatory and internal company standards.

+ Conduct regular audits and inspections to verify compliance with engineering standards and regulatory expectations.

+ Plan and manage project budgets, ensuring cost-effective use of resources and adherence to financial constraints.

+ Monitor project expenditures, analyze variances, and identify opportunities for cost savings.

+ Coordinate with vendors and suppliers to source and procure required materials, equipment, and services.

+ Identify and resolve technical issues that arise during project implementation to minimize disruption to operations.

+ Perform root cause analysis of engineering problems and develop effective corrective and preventive actions.

+ Apply innovative thinking and structured problem-solving methods to overcome project challenges and achieve desired outcomes.

+ Support and promote a culture of continuous improvement across manufacturing operations.

Essential Skills

+ Bachelor's degree in Engineering, such as Mechanical, Chemical, Electrical, or a closely related field.

+ At least 2 years of engineering experience in a manufacturing environment.

+ Proven track record of managing and executing engineering projects from planning through completion.

+ Hands-on experience in project engineering within manufacturing or industrial settings.

+ Strong knowledge of GMP and FDA regulations and their application in pharmaceutical manufacturing processes.

+ Proficiency in project management software and tools for planning, tracking, and reporting.

+ Demonstrated mechanical or process engineering capability, including process improvement and manufacturing engineering.

+ Strong problem-solving and analytical skills with the ability to address complex technical issues.

+ Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders.

+ Ability to manage multiple projects simultaneously, prioritize tasks, and meet deadlines.

+ High attention to detail and strong organizational skills to maintain accurate documentation and project records.

Additional

Skills & Qualifications

+ Experience in process improvement and continuous improvement initiatives within manufacturing environments.

+ Experience in mechanical or process engineering with exposure to manufacturing engineering practices.

+ Familiarity with structured project management methodologies and best practices.

+ Ability to collaborate effectively with vendors and suppliers to support project objectives.

+ Comfort working in regulated environments that require strict adherence to quality and compliance standards.

Work Environment

This role operates within a manufacturing facility that follows GMP and FDA regulatory standards, with a strong focus on product quality, safety, and compliance. The Project Engineer works closely with production lines, utilities, and support areas, regularly interacting with cross-functional teams such as production, quality assurance, and maintenance. The position involves both office-based tasks, such as project planning and documentation using project management software, and on-site activities, including equipment installation, commissioning,…