Project Engineer - Andover, United States - Ventura Solutions LLC

Ventura Solutions LLC Andover, United States

2 weeks ago

Description

Job Description

We are currently seeking a skilled and experienced Project Engineer to join our team and manage the delivery of capital projects related to utilities in Andover, Massachusetts. If you are a motivated individual with a passion for project management and a background in engineering, we want to hear from you

Role Description

As a Project Engineer, you will play a critical role in managing the delivery of capital projects related to utility systems at our client's Andover facility. You will report to Capital Project Managers and work closely with cross-functional teams to ensure projects are executed in accordance with the Capital Project Management Process (CPMP) and meet the needs of our client's organization. This role requires solid knowledge of utility system design and operation, as well as experience in process engineering, equipment validation, and GMP/biopharmaceutical environments.

Responsibilities

Manage the delivery of Capital Projects and other Utilities projects in accordance with the Capital Project Management Process (CPMP).
Work closely with Capital Project Managers to ensure projects are executed efficiently and effectively, meeting project objectives and timelines.
Lead the project design process with Architectural and Engineering (AE) firms or equipment vendors as required, ensuring designs meet project requirements and specifications.
Coordinate or perform review and approval of project submittals as required, ensuring compliance with regulatory requirements and industry standards.
Support automation integration efforts to optimize utility system performance and efficiency.
Conduct risk management and root-cause analysis for project-related issues, implementing corrective actions as necessary to mitigate risks and ensure project success.
Manage the User Requirement Specifications (URS) development process as required, ensuring alignment with project objectives and stakeholder needs.
Oversee validation execution performed by third parties, including Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs) for HVAC/cold room and other GMP utilities.
Coordinate training on equipment with suppliers and end users, ensuring proper use and maintenance of utility systems.

Qualifications

Bachelor's degree in engineering or a related field is required.
Solid knowledge of utility system design and operation, including HVAC, cold rooms, WFI, and compressed air systems.
Experience in process engineering and equipment validation per 21 CFR Part 11 is essential.
Experience working in a GMP/biopharmaceutical environment with an expert-level understanding of managing processes in such environments is highly desirable.
Strong project management skills with the ability to manage multiple projects simultaneously and meet project deadlines.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
Detail-oriented with strong analytical and problem-solving abilities.

Location

Andover, MA

Employment Type

Contract

Benefits

Choice of medical, dental, and vision plans
Paid vacation time
Competitive base salary
401(k)

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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