Engineering & Design (E&D) Lead

Validation & Engineering Group; 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 a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are 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.

Description:

• Lead and coordinate owner-side A/E design management across multiple projects.
• Support development of User Requirements Briefs (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.

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.

Tools / Systems Experience

• Teams / SharePoint
• Project - document-control, action, decision, risk, and design-review tracking tools

Preferred Experience

• Familiarity with, or ability to quickly adopt: IDEA project delivery methodology
• Design to Value (DTV)
• EHS by Design Phase-gate / phase-acceptance requirements
• Sustainability / LEED considerations

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.