Mechanical Engineering Specialist

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

We are seeking an experienced HVAC / Cleanroom Subject Matter Expert (SME) to support a major pharmaceutical capital project.

The successful candidate will provide technical leadership and governance for HVAC and cleanroom systems throughout the project lifecycle, from early design and specification through procurement, commissioning, qualification and start-up.

The role can be based anywhere in the U.S. but when the project kicks off you will need to be based close to the site in Virgina.

Key Responsibilities

• Provide technical direction and leadership for HVAC and cleanroom systems throughout the project lifecycle.
• Provide technical input into FEED and subsequent design stages.
• Translate project, GMP, engineering and operational requirements into technical specifications and design deliverables.
• Work closely with design contractors to develop and assure HVAC and cleanroom designs.
• Conduct design reviews and provide technical assurance throughout the design lifecycle.
• Review engineering drawings, specifications, calculations and technical documentation.
• Ensure HVAC and cleanroom User Requirement Specifications (URS) are complete and technically accurate.
• Support the technical assessment and selection of equipment suppliers and contractors.
• Provide technical input into procurement strategies and technical scopes.
• Ensure GMP, engineering and safety requirements are incorporated into the design.
• Participate in technical risk assessments and design reviews.
• Provide technical guidance to project and work package teams.
• Review relevant FAT, SAT, DQ, IQ and OQ documentation and protocols.
• Attend pre-FATs, FATs, mechanical completion inspections and SATs as required.
• Provide technical support throughout commissioning and qualification.
• Support resolution of technical issues during detailed design, commissioning and qualification.
• Support start-up and early operational activities.
• Contribute to lessons learned and continuous improvement.

Requirements

• Significant experience as an HVAC Engineer, Cleanroom Engineer, HVAC SME or Technical Authority within pharmaceutical, biotechnology or another highly regulated manufacturing environment.
• Strong experience with HVAC and cleanroom systems on major capital projects.
• Proven experience providing technical leadership, design assurance and technical governance.
• Strong understanding of GMP requirements and their application to HVAC and cleanroom systems.
• Experience across the project lifecycle from FEED and design through procurement, commissioning, qualification and start-up.
• Experience with URS development, technical specifications and vendor documentation.
• Experience with FAT, SAT, DQ, IQ and OQ.