Sr Project Engineer (Fit and Finish Engineer)

Fresenius Group; Melrose Park, Northern (IL, KY); Hybrid; USD 100,000 - 115,000; Full time

Benefits offered by this job

401k with company contributions

Medical, dental and vision coverage

Paid vacation, holidays and personal '

Employee assistance program

Wellness program

Life insurance

Disability

Job summary

Fresenius Kabi in Melrose Park, IL seeks a site engineer to lead complex manufacturing projects in a GMP environment, focusing on productivity, capacity and safety. You will design, implement and follow up on initiatives to improve processes and equipment efficiency.

You will collaborate with cross-functional teams, manage vendors, ensure regulatory compliance, and deliver projects on time and within budget. A Bachelor's in engineering and 5+ years in pharma manufacturing are preferred.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum 5 years engineering experience; pharmaceutical manufacturing preferred.
• Strong knowledge of FDA regulations and GMP.
• Proficiency with statistical analysis tools.
• Proactive with strong project management and teamwork.
• Able to read construction and process drawings.
• Excellent written and verbal communication and documentation skills.
• Ability to work independently and with cross-functional teams.

Responsibilities

• Execute site engineering projects with design, vendor coordination, and clear specifications.
• Deliver projects on time and within budget.
• Assess feasibility and cost/time for new projects, including BOM.
• Ensure compliance with state, federal, local codes including FDA/OSHA.
• Coordinate vendors and ensure safety and regulatory compliance.
• Prepare bid packages, funding requests, and project documentation.
• Maintain awareness of pharmaceutical manufacturing standards and drive improvements.
• Report project status to managers and sponsors.
• Prepare URS, risk and safety assessments when required.
• Analyze production problems and define project scope.
• Collaborate with multiple functional teams.
• Monitor energy use and propose savings; support ISO 50001.
• Support GMP environment and clean room reviews.
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Systems.

Skills

Project management

Analytical thinking

Interpersonal skills

Communication skills

Attention to detail

Problem solving

Documentation skills

Team collaboration

Education

Bachelor's in engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Project management software

Statistical analysis tools

Job description

Job Summary

Salary Range: $100,000 to $115,000

Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

Responsible for designing, communicating, implementing, and completing complex engineering project plans in a manufacturing facility. Using technical expertise to complete daily operations successfully through analysis, recommendation, implementation, and follow-up concerning projects designed to increase or improve productivity, capacity, or safety.

Job Responsibilities:

• Implements site engineering projects by employing experience, research, design and concept sketches, layouts, drawings, vendor interaction, preparation of specifications, discussions with appropriate management and site personnel.
• Ensures completion of the projects assigned by management is within timeline parameters and budget
• Evaluates the feasibility of conceptual projects and prepares detailed analysis, including time and cost for completing the projects, including detailed bill of materials
• Assures that assigned projects are in compliance with State, Federal and local codes which encompass environmental protection, FDA requirements, OSHA, and hazardous waste- related issues
• Directs and coordinates activities of various vendors for each project to eliminate any potential conflict and assures that vendors comply with all the safety rules and regulations
• Prepares and reviews project specifications, bid packages, funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules
• Maintains awareness of current pharmaceutical manufacturing needs and standards and initiates programs/projects to achieve the goal of facility being a state-of-the-art pharmaceutical manufacturing site
• Communicates and reports project status to departmental managers or department that sponsors the project
• Prepares URS, Risk Assessments, Safety Assessments associated with the project when required.
• Analyzes complex production and processing problems and initiate project definitions to resolve them
• Collaborates well with multiple functional teams
• May monitor and analyze energy consumption to identify energy savings opportunities and make recommendations to achieve more energy efficient operation
• May be responsible for maintaining or improvement the ISO 50001 energy management system
• May assists Manufacturing and Maintenance with solving problems, improving processes, and reducing costs
• Project execution in a GMP environment
• Facility clean room review
• knowledge in utilities and project management
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Job Requirements:

• Bachelors in technical science, engineering, or related field
• Minimum 5 years of engineering experience required. Pharmaceutical manufacturing industry preferred,
• Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
• Preferred technical knowledge and understanding of statistical analysis tools and methods
• Must be proactive, have experience with high performance teams, strong interpersonal and project management skills
• Computer-literate in word processing, spreadsheets, project management and power point desired Ability to generate and modify different reports
• Must possess a thorough understanding of mechanical, plant systems, as well as the ability to read construction and process drawings.
• Must be able to interact with varying levels within the company
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results and solve complex problems
• Must have good technical written and verbal communication skills, good documentation skills, good organizational skills, and good interpersonal skills to collaborate with the plant staff.
• Demonstrated ability to troubleshoot equipment utilizing strong analytical competency and tools.

The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental andvision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand Fresenius Kabi have the right to end the employment relationship at any time,in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.