Engineering & Design Lead - GMP Projects (Onsite)

Pinnaql, Inc.; Añasco (PR); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Equal opportunity employer

Onsite work in Puerto Rico

Job summary

Pinnaql is seeking an experienced Engineering & Design (E&D) Lead to support active projects at a GMP manufacturing site in Añasco, Puerto Rico. The role provides owner-side engineering and design management across multiple project phases, from early definition to closeout.

You will lead multidisciplinary design reviews, coordinate URBs and Basis of Design, manage design maturity and change processes, and ensure compliance with cGMP/GEP standards while onsite at least three days per week.

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 development of 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 A/E management

Multidisciplinary design reviews

GMP regulatory experience

Stakeholder management

Onsite availability

Tools

Teams

SharePoint

Document control tools

Job description

Pinnaql is seeking an experienced Engineering & Design (E&D) Lead to support active projects at a GMP manufacturing site in Añasco, Puerto Rico. The role provides owner-side engineering and design management across multiple project phases, from early definition to closeout.

You will lead multidisciplinary design reviews, coordinate URBs and Basis of Design, manage design maturity and change processes, and ensure compliance with cGMP/GEP standards while onsite at least three days per week.