Sr Project Engineer (Facilities Engineer)

Fresenius Kabi USA; Melrose (MA); On-site; USD 100,000 - 115,000; Full time

Benefits offered by this job

401(k) match

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits

Job summary

Fresenius Kabi USA in the United States is seeking an engineered-focused professional to design, communicate, and implement complex project plans in a pharma manufacturing facility. You will drive productivity, capacity, and safety through data-driven analysis and cross-functional collaboration with vendors and site personnel.

The role requires a strong background in engineering with 5+ years’ experience, familiarity with FDA regulations, and a proactive, detail-oriented approach to project

Qualifications

• Bachelor's degree in technical science, engineering, or a related field.
• Minimum 5 years of engineering experience.
• Pharmaceutical manufacturing industry preferred; knowledge of FDA regulations and GMP.
• Strong project management, analytical, and written/verbal communication skills.

Responsibilities

• Design, communicate, implement, and complete complex engineering project plans in a manufacturing facility.
• Improve productivity, capacity, or safety through analysis and implementation of projects.
• Ensure projects are within timeline and budget with proper specifications and vendor coordination.
• Comply with FDA requirements, OSHA, environmental and hazardous waste regulations.

Education

Bachelor's degree in technical science, engineering, or related field

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.
• 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 assist Manufacturing and Maintenance with solving problems, improving processes, and reducing costs
• Project execution in a GMP environment
• Facility knowledge in a clean room environment with knowledge of utilities
• 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.

Additional Information

The Company’s primary business language is English.

We offer an excellent salary and benefits package including medical, dental and vision 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 permanent employment arrangement. All employment is at‑will, meaning both the employee and 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 applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life.

Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr

If you have any questions at any stage of the process, contact us at [e-mail].