Manufacturing Equipment Specialist

Pinnaql, Inc.; Aguadilla (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Manufacturing Equipment Specialist to lead qualification of lab equipment and production systems at client sites in the pharmaceutical and biotech sectors.

You will verify equipment, prepare IQ/OQ protocols, maintain documentation, and coordinate with vendors and internal teams to ensure compliant qualification packages. Strong knowledge of GMP, GDP, and data integrity is required; English communication essential; Spanish preferred for site

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience developing and executing qualification protocols or CSV lifecycle documents and tests.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Working knowledge of GMP regulations, GDP, regulatory guidance, data integrity principles, risk-based qualification and validation, and FDA cGMP requirements 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.

Responsibilities

• Review the applicable User Requirements Specification, design documents, drawings, vendor manuals, commissioning records, calibration records, certificates, risk assessments, and other lifecycle documents.
• Confirm qualification boundary, components, prerequisites, test strategy, acceptance criteria, and needed documentation for protocol development and execution.
• Perform field walkdowns and document reviews to confirm readiness for qualification.
• Generate IQ/OQ protocol using current Company procedures and templates.
• Incorporate comments and support protocol routing until approval for execution.
• Execute approved IQ/OQ protocol in accordance with company procedures and GDP.

Education

Bachelor's degree in Engineering or related field

Job description

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.

Expected activities include the following as applicable:

• 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.

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.

Excited to build something meaningful together? We look forward to hearing from you.

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.