Senior Project Engineer - Fit...

Xtalks; Melrose Park (IL); Sur place; USD 80 000 - 100 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

PTO

401K

Résumé du poste

cGMP Consulting seeks an experienced engineer to design, communicate, implement and complete complex project plans in a pharmaceutical manufacturing environment. You will analyze feasibility, prepare detailed cost estimates, and coordinate vendors while ensuring compliance with FDA, OSHA, and local codes.

Responsibilities include preparing URS and safety assessments, reporting status to management, and driving energy efficiency and process improvements across facilities.

Qualifications

• Minimum 5 years of engineering experience; pharma manufacturing preferred.
• Excellent attention to detail and working knowledge of FDA regulations and GMP.
• Proficiency with statistical analysis tools is a plus.

Responsabilités

• Design, communicate, implement and complete complex engineering project plans in manufacturing.
• Evaluate feasibility, provide detailed time and cost analyses, and prepare BOMs.
• Ensure compliance with state, federal, local codes including FDA and OSHA requirements.
• Coordinate vendors, manage bid packages, and monitor safety and regulatory adherence.
• Prepare URS, risk and safety assessments as required for projects.
• Report project status to stakeholders and work with multi-functional teams.
• Identify energy savings opportunities and support ISO 50001 optimization where applicable.
• Assist manufacturing and maintenance with process improvements and cost reductions.

Connaissances

Attention to detail

Project management

Interpersonal skills

Statistical analysis tools

Regulatory compliance understanding

Formation

Bachelor's degree in engineering or related field

Outils

MS Word

MS Excel

PowerPoint

Description du poste

About Us

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals. cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.

Position Summary

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.

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.

Position Skills And 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.

Compensation And Benefits

• Expected pay range per year: $80,000-$100,000 USD
• Expected benefits include: Medical, Dental, Vision, PTO, 401K

Disclaimer

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.