C&Q Engineer, Sr.
C&Q Engineer, Sr.
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Job Description
Ultimate Solutions is a trusted provider of packaging industrial automation serialization and regulatory compliance for the life science industries. For 20 years the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical biotechnology medical devices and logistics markets.
Key Responsibilities:
- Plan coordinate and execute commissioning and qualification activities for equipment utilities automation systems and facilities.
- Develop and review C&Q documentation including protocols test scripts reports and traceability matrices.
- Perform Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) testing.
- Ensure equipment and systems meet design specifications user requirements and applicable regulatory standards.
- Work closely with project managers engineering validation automation quality and manufacturing teams to align on project timelines and deliverables.
- Troubleshoot and resolve issues identified during C&Q execution.
- Support change control deviation investigations and corrective/preventive action (CAPA) activities.
- Maintain compliance with GMP safety and environmental requirements throughout project execution.
- Ensure C&Q documentation is complete accurate and audit-ready.
- Bachelors degree in Engineering Life Sciences or related field.
- 5 years of experience in commissioning qualification or validation within a GMP-regulated environment.
- Strong understanding of IQ/OQ/PQ processes GMP regulations and industry standards (ISPE Baseline Guides ASTM E2500).
- Ability to read and interpret P&IDs electrical schematics and system design documents.
- Experience with automation systems process equipment and utilities in pharmaceutical or biotechnology manufacturing.
- Strong attention to detail and technical writing skills.
- Effective communication and teamwork skills.
- Must possess the ability to multi-task
- Must possess the ability to work under pressure.
- Ability to understand complex problems and to collaborate and explore alternative solutions.
- Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
- Ability to compose letters outlines and basic reports and/or to orally communicate technical information.
Ultimate Solutions USA LLC is an equal opportunity employer. The company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race color religion sex national origin disability status protected veteran status or any other characteristic protected by law.
Employment Type
Full Time
