Senior Project Engineer

BioSpace; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental Insurance

Pet Insurance

Company paid STD and LTD

3 Weeks’ Paid Time Off

Tuition Assistance

Job summary

A leading biopharmaceutical company in Boca Raton, FL, is seeking a Senior Project Engineer to provide engineering and project management support. Responsibilities include managing engineering projects, developing commissioning plans, and assisting in regulatory documentation for FDA submissions. The ideal candidate has a minimum of 10 years in a cGMP environment, possesses strong technical writing skills, and can thrive in a high-pressure setting. Competitive benefits package offered, including 401K and health insurance.

Qualifications

• Minimum of 10 years of engineering experience in a cGMP Pharmaceutical/Biological manufacturing environment.
• Ability to work in high-pressure, deadline-driven environment.
• Must possess exceptional organizational and communication skills.

Responsibilities

• Manage engineering projects by planning and tracking cross-functional teams.
• Develop commissioning plans for process and utility systems.
• Assist in writing regulatory documents for FDA submissions.

Skills

Project management

Problem-solving

Technical writing

Analytical skills

Time management

Tools

Microsoft Office

Project management software

Job description

ADMA Biologics

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Project Engineer in Boca Raton, FL!

Job Title: Senior Project Engineer

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 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 bottlenecks 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 performance against SOPs. Works to develop and maintain a collaborative and effective working relationship 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.

Benefits

• 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
• ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees.
• ADMA Biologics is an Equal Opportunity Employer.

To learn more about E‑Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.