6067 - GMP Project Engineer (Mechanical Focus) / Project Engineer

Verista, Inc.•Canton, MA

16d•Onsite

About The Position

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Overview 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°C warehouse freezer

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

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