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Veg Group

LL01-251104 - Engineering Technical Lead for Biotech Facilities Design

Veg Group, Juncos, Juncos, us, 00777

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Career Opportunities with Validation & Engineering Group A great place to work. Current job opportunities are posted here as they become available. LL01-251104 - Engineering Technical Lead for Biotech Facilities Design

Validation & Engineering Group, Inc.

(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Engineering Technical Lead - Biotech Facilities Design 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. Key Responsibilities Technical Leadership 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. Project Execution 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. Quality & Compliance 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. Client & Team Coordination 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. Qualifications Education Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, or related discipline). Experience 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. Skills 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 . 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.

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