Lead HVAC & Cleanroom Engineer - Pharma Capital Project

Blackfield Associates; Virginia (MN); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Blackfield Associates seeks an experienced HVAC / Cleanroom Subject Matter Expert to support a major pharmaceutical capital project. The SME will provide technical leadership and governance for HVAC and cleanroom systems from FEED through commissioning and start-up.

The role can be based anywhere in the U.S., with the project kick-off requiring proximity to the Virginia site. Candidates should have significant experience on regulated manufacturing projects and a track record of design assurance,

Qualifications

• Extensive experience as HVAC/cleanroom SME in regulated pharma environments.
• Lead design reviews, technical governance and URS development.
• Experience with FEED, FAT/SAT/IQ/OQ, and commissioning.
• Strong GMP knowledge and ability to translate requirements into specs.

Responsibilities

• Provide technical direction for HVAC and cleanroom systems through the project lifecycle.
• Collaborate with design contractors to develop and assure HVAC designs.
• Review drawings, specs, calculations, and documentation for compliance.
• Support procurement and qualification activities, risk assessments, and start-up.

Skills

HVAC systems design

Cleanroom engineering

Technical leadership

GMP knowledge

Job description

Blackfield Associates seeks an experienced HVAC / Cleanroom Subject Matter Expert to support a major pharmaceutical capital project. The SME will provide technical leadership and governance for HVAC and cleanroom systems from FEED through commissioning and start-up.

The role can be based anywhere in the U.S., with the project kick-off requiring proximity to the Virginia site. Candidates should have significant experience on regulated manufacturing projects and a track record of design assurance,