USP Purified Water Specialist

Working with Engineering, Maintenance, Quality, Validation, and Laboratory teams, this role keeps the system qualified, reliable, and compliant with cGMP requirements and site procedures, drawing on strong engineering, troubleshooting, qualification, and technical writing skills. The USP Purified Water Specialist provides technical expertise and hands-on support for the operation, monitoring, troubleshooting, qualification, and reliability of USP Purified Water systems and related utilities.

Client Overview:
For 50+ years, our client has built a reputation as a trusted name in consumer products, combining decades of manufacturing expertise with a steady commitment to quality and innovation. As a medium-sized company, they offer the stability of an established business with the agility and close-knit feel of a smaller team, where employees' contributions are visible and valued. They are currently looking to add a USP Purified Water Specialist to their team. Their culture is built on collaboration, respect, and continuous improvement, creating an environment where people genuinely enjoy coming to work and growing their careers.

Salary/Hourly Rate:
$35/hr - $45/hr, Based on applicable experience

Position Overview:
The USP Purified Water Specialist provides technical expertise and hands-on support for the operation, monitoring, troubleshooting, qualification, and reliability of USP Purified Water systems and related utilities. Working with Engineering, Maintenance, Quality, Validation, and Laboratory teams, this role keeps the system qualified, reliable, and compliant with cGMP requirements and site procedures, drawing on strong engineering, troubleshooting, qualification, and technical writing skills. The USP Purified Water Specialist is a 6 - 12-month contract role, on-site.

Responsibilities of the USP Purified Water Specialist:

• The USP Purified Water Specialist will provide technical oversight and support for USP Purified Water generation, storage, distribution, and points of use.
• Monitor operating parameters, perform routine inspections, and respond to alarms, excursions, and operational issues.
• Support system startup, shutdown, sanitization, recovery, and return-to-service activities.
• Troubleshoot pumps, valves, piping, instrumentation, controls, filtration, and water-treatment equipment.
• Support Maintenance and Engineering during shutdowns, repairs, modifications, and emergency response.
• Collect water samples per approved sampling plans and SOPs, and review data for trends or discrepancies.
• Support commissioning, qualification, and validation of water systems per cGMP requirements.
• Write, execute, review, and approve IQ/OQ/PQ protocols and qualification reports.
• Support system impact assessments, boundary definitions, and risk-based qualification strategies.
• Maintain accurate, traceable water-system logs, sampling, calibration, and qualification records.
• Assess system changes for qualification, validation, or compliance impact.
• Support audits, inspections, deviations, excursions, CAPAs, and root-cause investigations.
• Support preventive maintenance and reliability programs for water-system equipment.
• Evaluate alarms, failures, and trends to identify and implement improvement opportunities.
• Serve as a technical resource and mentor for water-system operation, troubleshooting, and qualification.
• Coordinate contractors and vendors on water-system projects and improvements.
• Communicate technical risks and investigation findings to stakeholders.
• The USP Purified Water Specialist must be able to lift and carry up to 50 pounds; stand, walk, bend, climb, kneel, and perform repetitive tasks for extended periods.
• Safely access utility and mechanical areas, working near pumps, piping, and electrical equipment.
• Follow applicable safety requirements, including Lockout/Tagout (LOTO), electrical safety, PPE, and confined-space procedures.
• Respond to off-shift emergencies and work overtime, weekends, or non-standard hours as needed.

Required Experience/Skills for the USP Purified Water Specialist:

• 5 - 8 years of direct experience with USP Purified Water systems - operation, monitoring, troubleshooting, and/or qualification.
• Experience in a pharmaceutical, cosmetic, personal-care, or other cGMP-regulated manufacturing environment.
• Experience commissioning and qualifying utility systems, including IQ/OQ/PQ activities.
• Experience developing or reviewing qualification protocols, validation reports, and technical documentation.
• Experience with system impact assessments and risk-based qualification approaches.
• Working knowledge of preventive maintenance and equipment reliability practices.
• Practical knowledge of water-treatment equipment, pumps, valves, piping, tanks, distribution systems, controls, and instrumentation.
• Experience with sampling, data review, investigations, and technical reporting, with strong cGMP documentation skills.

Preferred Experience/Skills for the USP Purified Water Specialist:

• Knowledge of USP Water for Pharmaceutical Purposes and industry expectations for pharmaceutical water systems.
• Technical experience with RO, EDI, UV treatment, filtration, storage and distribution systems, heat exchangers, pumps, valves, and instrumentation.
• Experience evaluating flow, pressure, temperature, conductivity, TOC, microbial trends, and sanitization performance.
• Experience investigating water-quality excursions, deviations, atypical results, and recurring issues.
• Experience with CAPA, change control, root-cause analysis, and risk assessments.
• Familiarity with ISPE Baseline Guides and risk-based commissioning/qualification principles.
• Experience supporting regulatory, customer, or internal quality audits.
• Experience with PLC-controlled equipment and computerized monitoring systems.
• Experience leading system upgrades, shutdowns, or capital improvement projects, and managing contractors or vendors.
• Experience developing SOPs, sampling plans, and technical reports, and mentoring technical staff.

Education Requirements:

• Bachelor's degree in Chemical, Mechanical, or Electrical Engineering, or a closely related engineering discipline is ideal for the USP Purified Water Specialist.

Benefits:

• Atrium Care Package available, upon eligibility (including healthcare plans, discount programs, and paid time off).

Job Wrapping ID: #LI-AJ3

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EOE/M/F/D/V/SO

Position ID: 412063