0018V6067 GMP Project Engineer (Mechanical Focus)

Two River Consulting Partners

Canton, MA, USA

Published: 6/14/2022

Manufacturing

Full Time

Job Description

Job Description0018V6067 GMP Project Engineer (Mechanical Focus)
Please contact Amanda Mazza, amanda@tworivercp.com

***FTE or Contractor***

KEY RESPONSIBILITIES
We are undertaking a major initiative to expand at the Canton, MA facility, increasing production from 40,000–50,000 units to 100,000 units next year. This effort includes improving equipment reliability, replacing aging assets, and expanding facility space to support higher-volume GMP operations.
We are hiring a GMP Project Engineer with a strong mechanical engineering foundation and a superintendent-style background to manage multiple facility modification and equipment installation projects.

Key Projects You Will Support:
You will lead or support approximately six capital projects ranging from $50K–$500K, including:

Build-out of an ISO 7 Cold Room
Refurbishment of an existing small laboratory space
Construction and qualification of an ISO 5 Suite
Conversion of a storage room into a final product incubator room
Upgrades and replacements to refrigeration systems
Installation of a -20&degree;C warehouse freezer

Project Engineer Responsibilities:

Plan, coordinate, and execute GMP facility and equipment projects within budget and timeline
Interpret and work from mechanical, electrical, and P&ID drawings
Oversee subcontractors performing building modifications, including casework, painting, and refurbishment construction
Ensure projects comply with FDA, GMP, and ISO standards
Collaborate cross-functionally with manufacturing, quality, facilities, and engineering teams
Support system start-up, commissioning, qualification, and documentation
Coordinate work during required non-traditional hours to minimize impact on operations
Drive improvements in equipment reliability and facility readiness to meet increased throughput goals

Requirements:

3–5 years of GMP project engineering experience
Mechanical engineering background with superintendent-style hands-on oversight
Ability to read and interpret electrical drawings and P&ID diagrams
Strong organizational and project management skills
Excellent cross-functional communication abilities
Experience working with subcontractors and trades
Experience working in ISO-classified environments (up to ISO Class 5)
Experience with temperature mapping for controlled temperature environments (CTE) and freezer rooms
Ability to work onsite 100% of the time in Canton, MA
Willingness to work Friday evenings and Saturday daytime shifts as required

LOCATION
On-site in Canton, MA

EMPLOYMENT
Competitive C2C or FTE

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