Senior Technology Professional

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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We are seeking a Senior Technology Professional to lead and support critical pharmaceutical operations. This role focuses on process control systems, and technical support for manufacturing, packaging, and laboratory equipment. Responsibilities include managing validation strategies, ensuring compliance with GMP and regulatory standards, troubleshooting complex systems, and providing technical leadership across multiple projects.

Key Responsibilities

Validation Strategy

• Define and manage validation strategies for computer systems and equipment.
• Draft user and functional specifications, risk assessments, and required documentation for qualification and validation in compliance with procedures.

Testing & Documentation

• Design and execute test procedures and acceptance criteria for FAT, IQ, and OQ.
• Ensure compliance with equipment, user, and regulatory requirements.
• Collect and document results, prepare SOPs for validated systems/equipment, provide training, and perform documents verification and transcription checks.

Project Management

• Manage multiple projects and priorities using project management techniques to anticipate roadblocks.
• Prepare and present business cases for capital projects.
• Own change controls and maintain project schedules.
• Design process control systems and specifications.
• Support and conduct technical investigations.

Technical Support & Compliance

• Provide technical expertise during audits, inspections, and due diligence.
• Support troubleshooting of process and lab equipment/control systems.
• Recommend improvements to processes, equipment performance, and product quality.
• Offer technical consultation across plant areas (Manufacturing, Packaging, Labs, etc.).
• Manage system software backup/restore and access control.
• Support operational projects and coordinate process control maintenance per GMP requirements.

• Bachelor’s degree in Science.
• Bilingual (Spanish/English).
• Strong computer literacy and technical skills in PLCs, SCADA, HVAC, and related technologies.
• Experience in pharmaceutical manufacturing processes, equipment operation, maintenance, and troubleshooting.
• Programming knowledge (Ladder Logic, Wonderware, Visual Basic) and working knowledge of AB and Siemens PLCs.
• Familiarity with GMP regulations and validation practices.

All your information will be kept confidential according to EEO guidelines.