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The Commissioning and Qualification (C&Q) Specialist is responsible for planning, executing, and documenting commissioning and qualification activities for new and existing facilities, systems, and equipment. This role ensures that all facilities, systems, and equipment meet regulatory requirements, industry standards, and organizational specifications. The specialist plays a crucial role in maintaining compliance, optimizing performance, and supporting the overall quality and efficiency of operations.
Responsabilities:
Commissioning and Qualification Planning:
Develop comprehensive commissioning and qualification plans for facilities, systems, and equipment.Define acceptance criteria and testing requirements based on regulatory standards and user requirements.Protocol Development and Execution:
Create detailed protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Execute qualification protocols and oversee testing activities.Documentation and Reporting:
Develop and manage changes related to the installation, commissioning, qualification activities through the change management system.Update procedures, forms, and validation documentation (including user requirements, system design specification).Prepare and review commissioning and qualification documentation, including test scripts, reports, and summary documents.Ensure all documentation meets regulatory requirements and organizational standards.Risk Assessment:
Conduct risk assessments related to equipment, systems, and processes to determine appropriate levels of qualification.Implement risk mitigation strategies as needed.Regulatory Compliance:
Ensure all commissioning and qualification activities comply with relevant regulations (e.g., FDA, EMA, ISO) and industry standards.Stay updated on regulatory changes and their impact on commissioning and qualification practices.Cross-functional Collaboration:
Work closely with project manager, site engineering staff, quality assurance, production, and other departments to coordinate commissioning and qualification activities.Provide technical support and guidance to project teams on commissioning and qualification matters.Continuous Improvement:
Identify and implement improvements to commissioning and qualification processes.Participate in root cause analysis and corrective action initiatives related to equipment or system performance issues.Training and Knowledge Sharing:
Develop and deliver training on commissioning and qualification processes to relevant staff.Share best practices and lessons learned from commissioning and qualification activities.Required:
Bachelor's degree in Engineering (Chemical, Mechanical, Electrical, or related)3-4 years experience in commissioning, qualification, or validationKnowledge of GMP, FDA, EMA, and ISO regulationsExperience with IQ, OQ, and PQ processesStrong technical writing and analytical skillsFamiliarity with risk assessment methodologiesProficiency in relevant software and documentation systemsAbility to work in cross-functional teamsAttention to detail and strong problem-solving skillsLocation:
On-site –Gurabo, PR, San Lorenzo, PRIf this job description resonates with you, we encourage you to apply, even if you don’t meet all the requirements. We’re interested in getting to know you and what you bring to the table!
Personalized benefits that support personal well-being and growth:
JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include:
401(k) plan with matching company contributions
Comprehensive Medical, Dental & Vision Care
Paid parental leave at 100% of salary
Paid Time Off and Company Holidays
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