Manufacturing Equipment Specialist

Pinnaql • Guaynabo, PR

20h

About The Position

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: Manufacturing Equipment Specialist. The Manufacturing Equipment resource will lead qualification of selected equipment assigned by the Company. Initial examples include biological safety cabinets and scales. Other equipment of comparable complexity may be assigned by mutual agreement.

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 equipment identification, installation, utilities, materials of construction, components, manuals, drawings, calibration status, and preventive maintenance information against approved requirements.
• Test equipment controls, operating ranges, displays, alarms, interlocks, safety functions, power loss and recovery behavior, and other required operational functions.
• For biological safety cabinets, verify and reference applicable certification data and test required airflow, pressure, alarm, HEPA filtration, lighting, and control functions within the approved qualification strategy.
• For scales, verify approved operating range, accuracy, precision or repeatability, linearity, display resolution, tare or zero functions, alarm or limit functions when applicable, and calibration traceability.
• Leverage approved vendor testing and certification when accepted by the qualification strategy and the Company procedures.
• Prepare separate or grouped qualification packages as directed by the Company based on equipment similarity, criticality, and document control requirements.
• 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

• 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.

What This Job Offers

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