Bachelor's degree in technical science, engineering, or related field.
5+ years of engineering experience, preferably in pharmaceutical manufacturing.
Strong knowledge of FDA regulations and Good Manufacturing Practices (GMP).
Proficient in statistical analysis tools and methods.
Excellent interpersonal and project management skills.
Responsibilities
Implement engineering projects using design, research, and vendor interaction.
Ensure projects are completed on time and within budget.
Evaluate project feasibility and prepare detailed analyses.
Ensure compliance with environmental, FDA, and OSHA regulations.
Coordinate vendor activities to prevent conflicts and ensure safety compliance.
Benefits
Medical, Dental, Vision insurance.
Paid Time Off (PTO).
401K retirement plan.
Full Job Description
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
The essential functions include, but are not limited to the following:
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.
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.
