LL01-251104 - Engineering Technical Lead for Biotech Facilities Design

Validation & Engineering Group•Juncos, PR

49d

About The Position

The Engineering Technical Lead Biotech Facilities Design is responsible for providing technical leadership, coordination, and oversight in the design and execution of biotechnology and pharmaceutical facility projects. This role ensures that all engineering disciplines deliver compliant, efficient, and cost-effective solutions aligned with GMP requirements, corporate standards, and project objectives from concept through detailed design and construction.

Requirements

Bachelors degree in Engineering (Mechanical, Chemical, Electrical, or related discipline).
Minimum 10 years of experience in engineering design for biotech, pharmaceutical, or life sciences facilities.
Proven experience as Lead Engineer, Area Engineer, or Technical Lead in GMP capital projects.
Strong understanding of bioprocess systems, clean utilities, and facility infrastructure.
Familiarity with design tools such as AutoCAD, Revit, or Plant 3D, and engineering management software.
Deep knowledge of GMP, ISPE Baseline Guides, and regulatory requirements.
Strong leadership, coordination, and communication skills.
Ability to manage multiple technical disciplines and stakeholders.
Experience supporting commissioning and qualification (C&Q) and process validation readiness.

Nice To Haves

Masters degree preferred.
Professional Engineer (P.E.) license or equivalent certification.
Experience with greenfield or large-scale expansion projects.
Familiarity with sustainability / LEED design principles for life science facilities.

Responsibilities

Lead the multi-disciplinary design team (process, mechanical, electrical, HVAC, plumbing, architectural, automation) throughout all project phases.
Provide technical guidance on facility layout, cleanroom design, process flow, and critical utilities (WFI, clean steam, process gases, HVAC, CIP/SIP).
Review and approve design deliverables, ensuring alignment with GMP, ISO, ASME-BPE, and client standards.
Serve as the technical liaison between engineering design teams, client stakeholders, and construction partners.
Support development of Basis of Design (BOD), User Requirement Specifications (URS), and Design Review Packages.
Oversee design coordination meetings and manage technical issues, RFIs, and change requests.
Ensure design integration with automation, process controls, and commissioning strategies.
Support procurement activities, equipment selection, and vendor technical reviews.
Collaborate closely with Construction, C&Q, and Validation teams to ensure a smooth handover from design to startup.
Ensure all designs comply with GMP, FDA, EMA, ISPE Baseline Guides, and EHS standards.
Lead or participate in HAZOP, design risk assessments, and constructability reviews.
Promote quality by design (QbD) principles and ensure design documentation meets audit expectations.
Act as the technical point of contact for client engineering and operations teams.
Communicate technical decisions clearly and document changes per project procedures.
Mentor junior engineers and coordinate discipline leads to maintain consistent engineering standards across deliverables.