Facilities Qualification Specialist

Pinnaql • Guaynabo, PR

1d

About The Position

Validation & Engineering Group, Inc. (V&EG) is seeking a talented and dedicated Facilities Qualification Specialist. This role involves leading the qualification of rooms, architectural elements, and supporting facility features within an approved scope. The specialist will verify various aspects of the facility against approved drawings and requirements, including room identification, boundaries, classifications, dimensions, finishes, penetrations, ceilings, walls, floors, coving, doors, windows, and other cleanable architectural features. Responsibilities also include verifying personnel and material access points, airlocks, pass-through interfaces, door functions, interlocks, seals, and room status indications. Additionally, the role involves confirming installed utility points, labels, fixtures, lighting, drains, and other facility features, as well as confirming applicable room pressure relationships and environmental conditions by coordinating with HVAC qualification testing. The specialist will review room readiness, document punch items or discrepancies, and utilize approved commissioning and turnover documentation as supporting evidence when permitted.

Requirements

• Bachelor's degree in Engineering or related field.
• Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests for the specific service area proposed.
• Prior experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Working knowledge of applicable GMP regulations, Good Documentation Practices (GDP), regulatory guidance, data integrity principles, risk-based qualification and validation, and industry standards relevant to the assigned scope, including FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles.
• Ability to interpret User Requirements Specifications, design documents, drawings, functional specifications, control narratives, vendor documentation, calibration records, and commissioning evidence.
• Demonstrated ability to write clear qualification or validation documents and reports and to execute testing accurately in the applicable field or computerized environment.
• Strong written and verbal communication skills in English.

Nice To Haves

• Spanish proficiency is preferred for effective site interaction.

Responsibilities

• Verify room identification, boundaries, classifications, dimensions where required, finishes, penetrations, ceilings, walls, floors, coving, doors, windows, and other cleanable architectural features against approved drawings and requirements.
• Verify personnel and material access points, airlocks, pass through interfaces, door functions, interlocks, seals, and room status indications within the approved facility boundary.
• Verify installed utility points, labels, fixtures, lighting, drains, and other facility features required by the approved design and qualification strategy.
• Confirm applicable room pressure relationships and environmental conditions by reference to or coordination with HVAC qualification testing.
• Review room readiness and document punch items or discrepancies that could affect qualification acceptance.
• Use approved commissioning and turnover documentation as supporting evidence when permitted by the Company procedures.
• Review the applicable User Requirements Specification, design documents, drawings, vendor manuals, commissioning records, calibration records, certificates, approved risk assessments, and other available lifecycle documents.
• Confirm the qualification boundary, system components, prerequisites, test strategy, acceptance criteria, and documentation needed to support protocol development and execution.
• Perform field walkdowns and document reviews needed to confirm that the system is ready for qualification.
• Generate an IQ/OQ protocol using the current Company procedure, template, and document control process.
• Incorporate review comments and support protocol routing until the protocol is approved for execution.
• Execute the approved IQ/OQ protocol in accordance with the Company procedures and Good Documentation Practices.
• Document discrepancies, exceptions, and deviations identified during execution and provide the technical information needed for assessment and resolution.
• Coordinate retesting after approved corrective actions when retesting is within the assigned scope and authorized hours.
• Assemble the executed protocol and supporting evidence into a complete package suitable for review and approval.
• Generate and maintain the Requirements Traceability Matrix linking applicable requirements to qualification tests and objective evidence.
• Generate the Qualification Summary Report describing the scope performed, results, deviations, open items, and conclusion on system qualification status.
• Support review comment resolution and final approval of the executed protocol, Requirements Traceability Matrix, and Qualification Summary Report.
• Maintain an accurate weekly forecast, deliverable tracker, and time record for the assigned work.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level