Design Team Leader

Position Summary

We are hiring a highly experienced and technically strong Design Team Leader to oversee the full design coordination for a large-scale biopharmaceutical manufacturing facility based in Texas. The successful candidate will lead multidisciplinary design teams, manage external consultants, and ensure that all architectural, structural, mechanical, electrical, and clean utility systems are delivered in alignment with regulatory and cGMP standards.

This role plays a pivotal part in ensuring seamless collaboration across design, construction, validation, and operationssupporting one of the most critical infrastructure builds in the life sciences sector.

Key Responsibilities

• Review project feasibility and confirm alignment with cGMP, FDA, and local regulatory requirements.
• Lead and coordinate design development across architectural, structural, HVAC, cleanroom, utility, electrical, and automation systems.
• Oversee the execution of design documentation, including P&IDs, general arrangement drawings, layout plans, and equipment specifications.
• Ensure all design packages comply with applicable standards including ISPE guidelines, ASME BPE, and ISO 14644 classifications.
• Manage both internal design resources and external engineering consultants to deliver high-quality and timely deliverables.
• Facilitate regular design review meetings and manage schedules, milestones, and technical approvals.
• Collaborate with procurement, construction, and commissioning teams to ensure seamless execution and integration.
• Implement digital coordination tools such as BIM, clash detection software, and project management platforms.
• Promote value engineering and sustainable design solutions to optimize space, cost, and energy performance.
• Support validation and permitting processes and engage with relevant regulatory authorities when required.
• Provide mentorship to junior engineers and maintain a culture of quality, innovation, and safety across the project team.

Required Qualifications

• Bachelors or Masters degree in Architecture, Mechanical/Electrical Engineering, or related field.
• Minimum 12 years of professional experience in facility design, with at least 3 years in biopharma/pharmaceutical or cleanroom environments.
• Strong knowledge of GMP, FDA, ISPE, EU GMP, ASME BPE standards, and cleanroom classification systems.
• Proficiency in design and collaboration tools such as AutoCAD, Revit, Navisworks, and BIM360.
• Demonstrated ability to manage multi-disciplinary teams and interface with a wide range of stakeholders.
• Excellent communication, leadership, and project coordination skills.
• Strong organizational skills and ability to manage fast-track design timelines.

Preferred Qualifications

• Previous experience designing facilities in Texas.
• Experience in international or multicultural project environments.
• Familiarity with commissioning and qualification processes (IQ/OQ/PQ).
• Experience in EPCM or design-build project models.
• LEED certification or strong knowledge of sustainable building practices.

Originally posted on Himalayas