GMP Engineering & Design Lead — Onsite Añasco

Veg Group

Añasco (PR)

On-site

USD 120,000 - 180,000

Full time

3 days ago
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Job summary

Pinnaql seeks an Engineering & Design Lead for a GMP site in Añasco, Puerto Rico. You will own design management across Concept to CDs, coordinating URBs, BODs, and construction documents with multiple stakeholders.

Lead reviews, manage design maturity and changes, ensure cGMP compliance, and support EHS by Design. You'll operate in an active facility, balancing shutdowns, cleanroom needs, and validated utilities with strong stakeholder collaboration.

Qualifications

  • Experience leading owner-side A/E/design management.
  • Experience through Concept, BOD, CDs.
  • GMP or regulated manufacturing environment experience.
  • Ability to work onsite 3 days/week in Añasco.
  • Strong communication and stakeholder management.

Responsibilities

  • Lead owner-side A/E design management across projects.
  • Develop URBs, feasibility studies, concept packages, and CDs.
  • Coordinate multidisciplinary reviews and close actions.
  • Lead BOD and CD design reviews and constructability reviews.
  • Manage design maturity and change processes.
  • Support EHS by Design reviews.
  • Coordinate interfaces among engineering, Operations, Facilities, CQV, IT/OT, and contractors.
  • Monitor RFIs and submittals during construction.
  • Ensure field readiness, handover, and CQV interfaces.

Skills

Engineering Leadership
A/E Design Management
GMP Environment
Stakeholder Management
Regulatory Compliance
Onsite Availability

Tools

Teams/SharePoint
Project Documentation Tools

Job description

Pinnaql seeks an Engineering & Design Lead for a GMP site in Añasco, Puerto Rico. You will own design management across Concept to CDs, coordinating URBs, BODs, and construction documents with multiple stakeholders.

Lead reviews, manage design maturity and changes, ensure cGMP compliance, and support EHS by Design. You'll operate in an active facility, balancing shutdowns, cleanroom needs, and validated utilities with strong stakeholder collaboration.

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