Design Verification Lead

Technical Engineering Consulting; Carolina (PR); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Technical Engineering Consulting is seeking an experienced Design Lead / Design Project Manager to support a major pharmaceutical capital project in Carolina, Puerto Rico. You will provide technical leadership and coordinate across the design and verification lifecycle, ensuring compliance with standards and regulatory requirements.

This role requires strong pharmaceutical engineering, design management, and cross-functional coordination, with travel about 25% and an initial 12-month assignment

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or Architecture.
• Minimum 5 years of manufacturing and/or engineering experience in pharma.
• Experience in regulated manufacturing environments with design scope.
• Strong PM, coordination, and communication skills.

Responsibilities

• Lead design delivery for assigned capital projects.
• Coordinate design activities with the Project Manager across all phases.
• Support Conceptual Design Reviews and Basic Design Reviews.
• Monitor design progress and ensure alignment with requirements.
• Facilitate design governance and issue resolution.

Skills

Design leadership

Project management

Regulatory compliance

Cross-functional coordination

Engineering design standards

A/E coordination

Change management

Design reviews

Problem solving

Education

Chemical Engineering

Mechanical Engineering

Architecture

Job description

Position Overview

We are seeking an experienced Design Lead / Design Project Manager to support a major pharmaceutical capital project in Carolina, Puerto Rico.

The selected professional will provide technical leadership and coordination throughout the engineering design and verification lifecycle, ensuring that project designs comply with applicable engineering standards, specifications, regulatory requirements, project objectives, and end-user requirements.

This position requires a strong combination of pharmaceutical engineering, design management, project management, technical leadership, and cross-functional coordination.

Location: Carolina, Puerto Rico
Schedule: Monday-Friday, approximately 40 hours per week
Contract Duration: Initial 12-month assignment with potential for extension
Travel: Approximately 25%, depending on project phase; domestic and international travel may be required

Key Responsibilities

• Lead identification and application of applicable engineering design standards, functional standards, engineering specifications, regulatory requirements, and industry guidance.
• Provide leadership and accountability for overall design delivery for assigned capital projects.
• Coordinate engineering design activities with the Project Manager throughout all phases of project execution.
• Coordinate and support Conceptual Design Reviews and Basic Design Reviews.
• Direct the development and alignment of project design requirements.
• Support development and maintenance of the engineering design schedule to meet project milestones.
• Participate in the evaluation and selection of Architecture/Engineering (A/E) firms.
• Coordinate with A/E firms and project stakeholders to monitor engineering progress by discipline.
• Facilitate timely engineering and design decisions and ensure effective information flow between design teams, system owners, technical specialists, and project leadership.
• Ensure engineering designs remain aligned with approved design intent and project/user requirements.
• Provide design governance and facilitate resolution of technical and design-related issues.
• Identify opportunities to improve engineering efficiency, design execution, and utilization of engineering hours.
• Support development and maintenance of project delivery procedures, work instructions, design/verification practices, and engineering best practices.
• Review and provide input regarding key project design personnel and technical resources.
• Coordinate with engineering resources, design specialists, project teams, system owners, and constructability resources to resolve design issues.
• Support replication strategies during design, where applicable.
• Participate in Value Engineering activities to identify opportunities for improved project value, constructability, quality, schedule, and cost.
• Participate in design performance and KPI reviews.
• Support selection and coordination of verification professional services.
• Provide accountability for development of the Project Verification Plan, Traceability Matrix, and applicable risk assessments.
• Coordinate verification activities with the Project Manager throughout the project verification phase.
• Support discrepancy tracking, resolution, and management during verification.

Minimum Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, another relevant Engineering discipline, or Architecture.
• Minimum of 5 years of manufacturing and/or engineering experience supporting pharmaceutical or Active Pharmaceutical Ingredient (API) operations.
• Demonstrated experience supporting engineering design, process engineering, project engineering, or capital projects within a regulated manufacturing environment.
• Strong project management, organization, communication, and technical coordination skills.
• Ability to work effectively with multidisciplinary engineering teams, project management, operations, technical specialists, contractors, and A/E firms.
• Ability to facilitate technical discussions and drive issues toward resolution.

Preferred Qualifications

• Pharmaceutical design, process engineering, or project engineering experience.
• Experience supporting pharmaceutical capital project delivery.
• Understanding of the engineering design lifecycle and A/E design activities.
• Experience coordinating multidisciplinary engineering teams.
• Experience with design reviews, design requirements, risk assessments, verification, and traceability.
• Strong stakeholder management and influencing skills.
• Ability to evaluate complex technical issues, facilitate decisions, and drive implementation.
• Demonstrated experience anticipating scope changes and facilitating technical issue resolution.
• Ability to balance safety, quality, schedule, cost, and project value during project execution.

Ideal Candidate

The ideal candidate is an experienced pharmaceutical engineering professional who can operate effectively between project management, engineering design teams, technical specialists, manufacturing users, and external A/E partners.

This individual should be comfortable leading technical discussions, coordinating multidisciplinary design activities, resolving engineering issues, and ensuring that design and verification deliverables support the overall objectives of a complex pharmaceutical capital project.