Clean Utilities Specialist Technician

R Dpartners; Munster; On-site; EUR 45,000 - 60,000; Full time

Job summary

R Dpartners is seeking a proactive Clean Utilities Specialist Technician to oversee the compliance, maintenance, and reliable operation of clean utility systems in a pharmaceutical manufacturing setting.

The role supports audits and inspections, ensures regulatory adherence, and drives continuous improvement initiatives across engineering and quality teams.

Qualifications

• Understanding of clean utility systems including water, clean steam, HVAC and compressed gases.
• Knowledge of GMP and regulatory guidelines (FDA, EU GMP Annex 1).
• Familiarity with validation (IQ/OQ/PQ) and computerized systems.
• Proficiency in data integrity and electronic records compliance.
• Ability to perform root cause analysis and implement corrective actions.
• Strong technical writing and report-generation skills.

Responsibilities

• Oversee compliance and performance of clean utility systems (water, clean steam, HVAC, gases).
• Ensure systems meet regulatory standards and maintain sanitization protocols.
• Investigate system issues and implement corrective actions to prevent recurrence.
• Monitor data for accuracy, security, and regulatory compliance.
• Prepare for and support regulatory inspections and audits.
• Collaborate with engineering and quality teams on concerns.
• Maintain documentation and generate reports for compliance and performance.
• Lead system upgrades, validations, and troubleshooting activities.

Skills

Clean utility systems

GMP knowledge

Regulatory compliance

Validation IQ/OQ/PQ

Data integrity

Root cause analysis

Technical writing

Documentation and reporting

Collaboration

Job description

Be the backbone of innovation and join a leading pharmaceutical company to help keep life-changing science moving forward!

R&D Partners is seeking a proactive Clean Utilities Specialist Technician to oversee the compliance, maintenance, and reliable operation of clean utility systems within a pharmaceutical manufacturing environment. This role is instrumental in ensuring adherence to regulatory requirements, supporting audits and inspections, and contributing to continuous improvement initiatives.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Oversee the compliance and performance of clean utility systems like water systems, clean steam, HVAC, and compressed gases.
• Ensure all systems meet regulatory and quality standards, including proper sanitization and maintenance protocols.
• Conduct investigations into system issues and implement corrective actions to prevent future occurrences.
• Monitor and review data for accuracy, security, and compliance with regulatory requirements.
• Prepare for and support regulatory inspections and audits.
• Collaborate with cross-functional teams to address engineering and quality concerns.
• Maintain accurate documentation and generate reports for compliance and performance tracking.
• Lead and support system upgrades, validations, and troubleshooting activities.

Key Skills and Requirements:

• Strong understanding of clean utility systems, including water systems, clean steam, HVAC, and compressed gases.
• Knowledge of Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., FDA, EU GMP Annex 1).
• Familiarity with validation processes (IQ, OQ, PQ) and computerized systems used in clean utilities.
• Proficiency in data integrity principles and electronic record compliance.
• Ability to conduct root cause analysis and implement effective corrective actions.
• Strong technical writing skills for reports and protocols.
• Comfortable using quality management systems and tools for tracking and reporting.
• Team-oriented with excellent problem-solving and communication skills.