Senior Mechanical Utilities Engineer

TAI Engineering has consistently been recognized by professional publications such as Engineering News News-Record) and Baltimore Business Journal (BBJ) as a Top National Design Firm in the US, Top Company, and Fastest Growing Company. We have an immediate opening for a Senior Mechanical Utilities Engineer to support the GMP critical, critical, non-critical mechanical systems for our growing Life Sciences, Pharmaceutical clientele in Maryland, Texas and Delaware!
The Mechanical SME will support multiple large-scale projects at locations throughout the United States. Key responsibilities include the following:

• Prepare the User Requirement Specification (URS's) for each GMP system, assure they are complete (GMP, GEP and SHE requirements), technically correct and appropriate for C&Q execution.
• Champion the timely engagement, review and approval of URSs with Customer team.
• Review Design Contractor enquiry specifications and Involvement in the bid review/ selection for these systems
• Review all documentation (drawings & calculations) within this area to ensure correct interpretation of client requirements.
• Work with the Design Contractor to develop the design, translating client technical requirements into Engineering deliverables.
• Containment philosophy review
• Room classification, GMP zoning and room data sheet review
• Review and approve FATs, SATs, DQ, IQ and OQ protocols for these systems (as required).
• Attend relevant pre-FATs, FATs, mechanical completion inspections & SATs to assure completeness and correctness of equipment packages.
• Provide technical support to system Commissioning and Qualification activities.

Technical Requirements/Qualifications:

• Bachelor's degree in mechanical engineering
• 10+ years of experience, 3+ within the Pharma/Biotech/Life Science industry.
• Professional Engineer license is desired.
• Experience preparing User Requirement Specification (URS's) for GMP systems.
• Strong background supporting mechanical systems for non-critical, critical, and GMP critical. Including, but not limited to:
  • HVAC
  • Clean Utilities
  • Black Utilities
• Experience developing and/or reviewing mechanical construction packages.
• Experience FATs, SATs, DQ, IQ and OQ protocols for mechanical systems.
• Strong collaborator with ability to create and maintain effective working relationships and willing to challenge behaviors and actions.
• Demonstrated practitioner of practical problem-solving.
• Detail focused completer/finisher with a results-orientated mindset.
• Strong leadership qualities with motivational ability to direct others in a dynamic and complex environment through change.
• Collaborate and work in partnership with multiple customer teams to deliver program/project objectives,
• High professional standards, holding themselves and other in the team to deliver high quality outcomes to committed deadlines.
• Works with integrity and tenacity to 'do the right thing' even under challenging situations.

If you're interested in learning more about TAI Engineering and what made us a top-20 partner in the manufacturing sector per Engineering News-Record (ENR), please visit us at www.taiengineering.com.