Facilities Qualification Specialist

Veg Group; Aguadilla (PR); Sur place; USD 65 000 - 95 000; Plein temps

Résumé du poste

Validation & Engineering Group, Inc. (V&EG) seeks a Facilities Qualification Specialist to lead room and facility qualification activities within approved scope. You will verify architectural features, room readiness, and utility points, and generate qualification documentation and reports.

The role requires a Bachelor’s degree in Engineering, GMP/GDP experience, and strong English communication skills. Spanish preferred for site interaction; position is on-site in Puerto Rico.

Qualifications

• Bachelor's degree in Engineering or related field required.
• Experience writing qualification or validation documents.
• Knowledge of GMP, GDP, and FDA 21 CFR Part 11 guidance.
• Ability to interpret specs, drawings, and vendor docs.

Responsabilités

• Review User Requirements, design docs, and lifecycle records to support qualification.
• Generate IQ/OQ protocols and manage routing until approval.
• Execute IQ/OQ protocols per company procedures and GDP.
• Document discrepancies and deviations for assessment and resolution.
• Coordinate retesting after corrective actions within scope.
• Assemble executed protocols and evidence into complete review packs.
• Create and maintain Requirements Traceability Matrix and Qualification Summary Report.
• Support final review, approval, and weekly deliverable tracking.

Connaissances

Qualification protocol writing

CSV lifecycle knowledge

GMP/GDP awareness

English communication

Formation

Bachelor's degree in Engineering or related field

Description du poste

Validation & Engineering Group, Inc.(V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Facilities Qualification Specialist

The Facilities resource will lead qualification of the rooms, architectural elements, and supporting facility features within the approved scope.

Expected activities include the following as applicable:

• 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.

Scope of Work:

The assigned qualification resource shall perform the following activities for each system or equipment item included in the approved assignment:

• 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.

Qualifications:

• 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. Spanish proficiency is preferred for effective site interaction.

At Validation & Engineering Group, 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.

Validation & Engineering Group 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.