Facilities Validation Program Manager – Medical Devices

EQVAL Group, Inc

Juncos (PR)

Hybrid

USD 95,000 - 130,000

Full time

40 hours ago
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Benefits offered by this job

Professional Growth (EQVAL Academy)
Referral Program

Job summary

EQVAL Group, Inc. seeks a Facilities Program Manager to support validation and qualification of CAS, Dryers, and AHUs/HVAC at a Puerto Rico facility. You will coordinate engineering, quality, and manufacturing teams, ensuring compliance and timely deliverables.

Travel may be required; remote work is allowed for documentation development, with on-site presence during testing activities. Fluency in English and Spanish is required to communicate across sites and regulatory documents.

Qualifications

  • Experience in pharmaceutical or medical device manufacturing environments.
  • Develop and execute validation and qualification protocols for CAS, Dryers, AHUs/HVAC.
  • Experience with critical utilities in controlled manufacturing environments.
  • Ability to independently execute qualification activities and document outcomes.

Responsibilities

  • Develop, review, and execute qualification and validation protocols for CAS, Dryers, and AHUs/HVAC.
  • Support commissioning and qualification activities (IQ, OQ, PQ).
  • Review validation documentation and leverage established strategies for new systems.
  • Ensure activities comply with regulatory requirements and internal procedures.
  • Prepare and maintain qualification reports and records.
  • Coordinate on-site testing with engineering, quality, and manufacturing teams.
  • Support qualification activities during scheduled manufacturing shutdowns.
  • Manage deliverables to meet project milestones and deadlines.
  • Travel may be required.

Skills

Bilingual English Spanish
Technical writing
Project coordination
Independent execution
Timelines management

Job description

EQVAL Group, Inc. seeks a Facilities Program Manager to support validation and qualification of CAS, Dryers, and AHUs/HVAC at a Puerto Rico facility. You will coordinate engineering, quality, and manufacturing teams, ensuring compliance and timely deliverables.

Travel may be required; remote work is allowed for documentation development, with on-site presence during testing activities. Fluency in English and Spanish is required to communicate across sites and regulatory documents.

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