Autoclave And Supporting Utility Qualification Specialist

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:

Autoclave and Supporting Utility Qualification Specialist

The External Autoclave and Supporting Utility resource will lead qualification of the autoclave located in San Juan and the associated water and Clean Steam Generation systems within the approved qualification boundary.

Review available facility, design, commissioning, vendor, maintenance, calibration, operating, and prior qualification documentation; perform field assessments; confirm equipment and utility boundaries and interfaces; and document gaps, prerequisites, and readiness constraints.
Develop or revise applicable lifecycle documents, which may include the User Requirements Specification, risk assessment, Validation Plan, IQ/OQ/PQ protocols, data sheets, Requirements Traceability Matrix, discrepancy or deviation records, and Validation or Qualification Summary Report.
Define and execute the approved qualification strategy, including applicable installation verification, utility verification, controls and alarm testing, cycle parameter testing, chamber distribution or mapping, load penetration studies, challenge testing, reproducibility, and acceptance criteria based on intended use and documented risk.
Verify or qualify the supporting water and Clean Steam Generation systems within the approved scope, including applicable generation, distribution, quality attributes, sampling, monitoring, controls, alarms, and interfaces with the autoclave.
Coordinate equipment availability, approved loads, calibrated instruments, biological or chemical indicators when applicable, sampling, laboratory support, safety requirements, and other prerequisites needed for execution.
Document development may be performed remotely when authorized.
Periodic visits to the San Juan equipment location and the Aguadilla facility are required, and protocol execution and other field activities shall be performed on site in San Juan.
Manage discrepancies, deviations, corrective actions, and retesting through approval and deliver a complete, inspection-ready qualification package for the Company review and closure.

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