Project Engineer

Bimeda•Ottawa Township, MN

113d

About The Position

The Project Engineer at our pharmaceutical manufacturing site will be responsible for planning, executing, and overseeing engineering projects to enhance the facility's efficiency, productivity, and compliance with regulatory standards. This role involves collaboration with various departments, including production, quality, and maintenance, to ensure the successful implementation of projects within budget and timeline constraints. The Project Engineer will utilize their technical expertise to solve complex problems, innovate processes, and support the continuous improvement of manufacturing operations.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related field).
Minimum of 3-5 years of engineering experience in a pharmaceutical or manufacturing environment.
Proven track record of managing and executing engineering projects.
Strong knowledge of GMP, FDA regulations, and pharmaceutical manufacturing processes.
Proficiency in project management software and tools.
Excellent problem-solving and analytical skills.
Effective communication and interpersonal skills.
Ability to manage multiple projects simultaneously and meet deadlines.
Strong attention to detail and organizational skills.

Nice To Haves

Relevant certifications (e.g., PMP) are a plus.

Responsibilities

Develop detailed project plans, including scope, objectives, timeline, and budget.
Coordinate and manage engineering projects from conception to completion, ensuring they meet the defined goals.
Conduct feasibility studies and risk assessments for proposed projects.
Provide technical support and expertise in the design, installation, and commissioning of equipment and systems.
Develop engineering solutions to improve manufacturing processes, reduce costs, and enhance product quality.
Ensure all engineering activities comply with GMP, FDA, and other regulatory standards.
Work closely with production, quality assurance, maintenance, and other departments to ensure project alignment with operational needs.
Facilitate effective communication among project stakeholders, providing regular updates on project status and progress.
Lead or participate in cross-functional teams to support continuous improvement initiatives.
Prepare and maintain detailed project documentation, including plans, reports, and records.
Ensure all project activities are properly documented and comply with regulatory and company standards.
Conduct regular audits and inspections to ensure compliance with engineering standards and regulations.
Develop and manage project budgets, ensuring cost-effective use of resources.
Monitor project expenditures and identify opportunities for cost savings.
Coordinate with vendors and suppliers to procure necessary materials and services.
Identify and resolve technical issues that arise during project implementation.
Conduct root cause analysis of engineering problems and develop corrective actions.
Utilize innovative thinking to overcome project challenges and achieve desired outcomes.