Project Engineer
Location: Boca Raton, FL
Job Type: Direct Hire
Company: Openwork
Salary: 0
Category: Engineering
Job Description Apply Now
The role of Project Engineer is central to supporting engineering, project management, manufacturing, and maintenance operations within a GMP manufacturing environment. As a Project Engineer, you will be instrumental in troubleshooting and resolving issues related to existing manufacturing processes and equipment. Your expertise will drive the development and implementation of engineering solutions that enhance process efficiency and reliability. In this dynamic role, you will contribute to capital engineering and process improvement initiatives and play a key part in the design, procurement, and commissioning of new process and utility equipment, as well as upgrades to existing systems.
Project Engineers in a GMP manufacturing site are responsible for managing projects ranging from mid- to large-scale, requiring close coordination with cross-functional teams and external contractors. You will be expected to plan, execute, and track project activities, ensuring that projects are delivered on time and within budget. This includes developing detailed schedules and performance requirements, performing risk assessments, and utilizing data-driven approaches to predict trends and optimize operating procedures. Your ability to develop and review process flow diagrams and piping and instrumentation drawings (P&IDs), and to prepare comprehensive commissioning plans, will be critical to ensuring that all systems and equipment meet required standards for their intended use.
As a Project Engineer, you will also be involved in technical writing, preparing documentation such as engineering evaluations, change control documents, testing plans, and corrective and preventive actions (CAPAs). You will lead or participate in investigations to determine root causes of process system or equipment issues, ensuring appropriate corrective actions are implemented. Your technical acumen will be leveraged to develop preventive maintenance plans and to provide troubleshooting expertise across all areas of plant operations and maintenance.
In this role, you will serve as the technical liaison during OSHA and other regulatory audits that pertain to facility and maintenance operations. Your responsibilities will also include assisting with the preparation of regulatory documents for FDA submissions as needed, and handling capital expenditure requests and purchase requisitions to facilitate the procurement of essential equipment and systems. The Project Engineer position is designed for individuals who possess a strong background in engineering within pharmaceutical, biologics, or biotechnology manufacturing environments, and who are capable of managing complex projects in compliance with stringent regulatory standards.
Project Engineer - Summary- Supports engineering, project management, manufacturing, and maintenance within a GMP facility.
- Drives process improvement and capital project initiatives.
- Responsible for troubleshooting, technical documentation, and regulatory compliance.
- Acts as a technical liaison during audits and regulatory submissions.
- Manage mid-to-large scale engineering projects with cross-functional teams and contractors.
- Plan and track project activities to meet scope, schedule, and budget goals.
- Analyze project resources and perform risk management to minimize project risks.
- Develop and execute commissioning plans for process and utility systems and equipment.
- Create and review process flow diagrams and P&IDs for system modifications and new implementations.
- Direct or assist in the design and execution of capital projects.
- Support engineering development with technical calculations such as flow, capacity, and pressure.
- Utilize technical writing skills for evaluations, change controls, testing plans, and CAPAs.
- Lead or assist in investigations of process systems and equipment issues to determine root causes and corrective actions.
- Employ statistical tools to analyze data, predict trends, and improve procedures and equipment reliability.
- Develop preventive maintenance plans and provide troubleshooting for manufacturing and utility equipment.
- Serve as a technical liaison for OSHA, regulatory, and other maintenance-related facility audits.
- Assist in writing regulatory documents for FDA submissions as required.
- Create capital expenditure requests and purchase requisitions for process and utility systems and equipment.
- Competitive base salary, commensurate with experience and qualifications.
- Comprehensive benefits package typically available for full-time employees.
- Opportunities for professional development and career growth in the engineering and biotechnology sectors.
- Bachelor's degree in Mechanical, Biochemical, or Chemical Engineering.
- Depending on experience, candidates may qualify for Associate, Project, or Senior Project Engineer levels, ranging from 3 to 10+ years of relevant engineering experience in cGMP pharmaceutical, biologics, or biotechnology manufacturing.
- Proven ability to coordinate and complete complex projects.
- Excellent written, oral communication, and presentation skills.
- Proficiency in computer applications including word processing, data entry, MS Project or Smartsheets, AutoCAD, and maintenance planning software.
- Strong problem-solving, mechanical aptitude, mathematical, and statistical analysis skills.
- Detail-oriented and skilled in engineering project management and process improvement.
- Experienced in a GMP-regulated manufacturing environment.
- Comfortable interfacing with cross-functional teams and external contractors.
- Skilled in technical documentation, troubleshooting, and compliance activities.
- Adaptable, analytical, and committed to quality and process optimization.
- The Project Engineer role offers a stimulating work environment in a robust industry sector, with opportunities to contribute to process innovation and regulatory excellence.
- Working in this position provides exposure to industry-leading practices in engineering and manufacturing.
- Candidates are encouraged to apply by clicking the job application button to join a team dedicated to operational excellence and continuous improvement in the manufacturing sector.
The company is an Equal Opportunity Employer and complies with all applicable laws and regulations regarding equal employment opportunity.