Onsite GMP E&D Lead – Life Sciences

Validation-; Añasco (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

Pinnaql is seeking an experienced Engineering & Design (E&D) Lead to support a portfolio of active and emerging projects at an operating GMP manufacturing site in Añasco, Puerto Rico.

The E&D Lead will provide owner-side engineering and design management across multiple project phases, including early project definition and feasibility, Concept, Basis of Design (BOD), Construction Documents (CDs), Construction Administration, and project closeout.

Qualifications

• Demonstrated experience in Engineering & Design leadership or owner-side A/E/design management.
• Experience managing engineering/design activities through Concept, BOD, CDs, and construction support.
• Experience leading multidisciplinary design reviews, comment management, issue resolution, and readiness to advance between project phases.
• Experience with constructability reviews and Construction Management/pre-construction interfaces.
• Experience working in GMP or similarly regulated operating manufacturing environments.
• Understanding of cGMP/GEP, design quality, engineering standards, change management, and project governance.
• Ability to support 40 hours per week and a minimum of three days per week onsite in Añasco.
• Strong communication, coordination, stakeholder-management, and documentation skills.

Responsibilities

• Lead and coordinate owner-side A/E design management across multiple projects.
• Support URBs, Feasibility Studies, Concept Packages, A/E RFP packages, Basis of Design, and Construction Documents.
• Coordinate multidisciplinary engineering and design reviews and drive comments, issues, and actions through disposition and closure.
• Lead BOD and CD design reviews and coordinate constructability reviews with Construction Management/pre-construction teams.
• Manage design maturity and design-change processes as projects progress from BOD through CDs.
• Support deployment and tracking of applicable engineering standards and SDPs.
• Support Design to Value (DTV) activities and project readiness for phase advancement.
• Support EHS by Design reviews throughout applicable project phases.
• Coordinate interfaces among engineering disciplines, Operations, Facilities, Maintenance, Utilities, EHS, Quality/CQV, IT/OT, A/E partners, construction teams, OEMs, and other stakeholders.
• Monitor RFIs, shop drawings/submittals, technical dispositions, and associated design impacts during construction.
• Support field execution readiness, design handover, vendor information, as-built documentation, and CQV/Operations interfaces.
• Maintain appropriate project action, decision, risk, standards-compliance, and design-review tracking.
• Support project reporting and governance, including scope, schedule, cost, risks, decisions, and actions.
• Capture lessons learned and opportunities for continuous improvement throughout the project lifecycle.
• Work effectively within an active operating facility while considering shutdowns, cleanroom requirements, validated utilities, construction isolation, and business-continuity constraints.

Skills

Engineering leadership

Owner-side design management

Concept-to-CDs

Design reviews

Constructability reviews

GMP experience

cGMP knowledge

Onsite availability

Stakeholder management

Documentation skills

Tools

Teams

SharePoint

Document-control systems

Job description

Pinnaql is seeking an experienced Engineering & Design (E&D) Lead to support a portfolio of active and emerging projects at an operating GMP manufacturing site in Añasco, Puerto Rico.

The E&D Lead will provide owner-side engineering and design management across multiple project phases, including early project definition and feasibility, Concept, Basis of Design (BOD), Construction Documents (CDs), Construction Administration, and project closeout.