Project Engineer, Manufacturing Engineer

Location: Le Sueur

Role Summary

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.

Key Role Specific Requirements

Project Planning and Execution:

• 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.

Technical Expertise:

• 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.

Cross-functional Collaboration:

• 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.

Documentation and Compliance:

• 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.

Budget and Resource Management:

• 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.

Problem-solving and Troubleshooting:

• 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.

Please note that this job description is not exhaustive and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

ACCOUNTABILITY/EXECUTION - A willingness to accept responsibility or to account for one's actions. Accountability is when an individual or a department experiences consequences for their performance or actions.

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.

INTEGRITY/PERSONAL CREDIBILITY - Demonstrated ability and concern that one be perceived as responsible, reliable, and trustworthy.

PROBLEM-SOLVING - Is the ability to find solutions to complex problems quickly; know how to identify problems and strengths; good analytical skills.

COMPLEXITY/STRESS MANAGEMENT /TIME MANAGEMENT-The ability to keep functioning effectively when under pressure and maintain self-control in the face of hostility or provocation. Cuts through complexity to focus on core issues; ability to manage time smartly; manages resources soundly.

Other Requirements

Education:

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related field).
• Relevant certifications (e.g., PMP) are a plus.

Experience:

• Minimum of 3-5 years of engineering experience in a pharmaceutical or manufacturing environment.
• Proven track record of managing and executing engineering projects.

Skills:

• 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.

What We Offer

• Health Insurance (medical, dental, vision).
• 401(k) plan for retirement savings.
• Paid time off (vacation, sick leave, holidays).
• Life insurance.
• Employee assistance program.

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