Engineering & Design (E&D) Lead

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

• Bluebeam
• Autodesk / Autodesk Construction Cloud (ACC)
• AutoCAD or similar design tools
• 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
• SDPs / Engineering Standards
• 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 youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its 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.

Required Experience:

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