Senior Project Engineer

Job Description:

Position Summary

The general purpose of the Senior Project Engineer is to provide engineering, project management, manufacturing and maintenance support to the GMP manufacturing site. Ability to troubleshoot, problem solve and implement engineering solutions for existing manufacturing processes and equipment. Direct, evaluate and assist capital engineering and process improvement projects. Design, procure and commission new process and utility equipment and upgrades to existing systems.

Essential Functions (ES) and Responsibilities

• Managing mid-to-large sized engineering projects by planning and tracking activities of cross-functional teams and contractors. Develop schedules and performance requirements using appropriate verification tools and techniques to manage project scope, schedule and cost ensuring that project goals are met on time and within budget. Analyze resources and priorities to be applied to assigned projects and perform risk management activities to minimize project risks.
• Develop and execute commissioning plans to ensure that process and utility systems and equipment are suitable for their intended use
• Develop and review process flow diagrams and piping and instrumentation drawings (P&IDs) for new process and utility systems and modifications to existing systems
• Direct and or assist in the design and execution of all capital projects assigned.
• Support engineering development with load calculations of flow, heating/cooling capacity, pressures, etc.
• Utilize strong technical writing skills to prepare engineering evaluations, change control documentation, testing plans, corrective and preventive actions (CAPAs)
• Lead and assist in investigations of process systems and equipment to determine and document root cause and ensure the appropriate corrective actions are initiated and implemented. Use statistical tools in analyzing data to predict trends, measure process capability, improve operating procedures or preventative maintenance procedures, identify bottle necks and equipment reliability.
• Help develop efficient PM plans for all key pieces of manufacturing and utilities equipment and provide troubleshooting expertise in all areas of plan operations and maintenance.
• Serve as the technical liaison for all OSHA, regulatory and other audits that relate to the maintenance/facility aspects of the manufacturing facility
• Assist in writing regulatory documents for FDA submissions as required.
• Create capital expenditure requests and purchase requisitions for approvals prior to procurement of process and utility systems and equipment

Job Responsibilities or Job Requirements

Competencies

Ability to follow the cGMP's and procedures with great attention to detail
Ability to read and understand blueprints
Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures
Able to work in high-pressure, deadline-driven environment
Actively provides feedback to operations management and staff regarding staff performanceagainst SOPs. Works to develop and maintain a collaborative and effective workingrelationship with operations management
Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project)
Excellent problem-solving and analytical skills and be able to frame issues clearly for less technical colleagues and customers
Exceptional organizational and communication skills required
Good mechanical aptitude and knowledge of general maintenance
Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs
Must have excellent writing and oral skills
Outstanding interpersonal, verbal, and written communication skills - must be able to translate technical concepts into non-technical terms for both senior level management and frontline staff
Possess time management skills and be able to balance multiple job assignments at once

Experience Requirements

• Minimum of 10 years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks' Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station