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C&Q Specialist
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary
We are seeking a highly motivated Commissioning & Qualification (C&Q) Specialist to support qualification and validation activities within a regulated pharmaceutical manufacturing environment. The successful candidate will be responsible for planning, developing, coordinating, executing, and documenting commissioning, qualification, and computer system validation activities while ensuring compliance with current regulatory requirements, internal quality standards, and project objectives.
Key Responsibilities
Position Summary
We are seeking a highly motivated Commissioning & Qualification (C&Q) Specialist to support qualification and validation activities within a regulated pharmaceutical manufacturing environment. The successful candidate will be responsible for planning, developing, coordinating, executing, and documenting commissioning, qualification, and computer system validation activities while ensuring compliance with current regulatory requirements, internal quality standards, and project objectives.
Key Responsibilities
- Manage and execute commissioning, qualification, and computer system validation activities for manufacturing systems, utilities, equipment, and computerized systems.
- Develop, review, and execute validation and qualification lifecycle documentation, including protocols, test scripts, reports, assessments, and supporting records.
- Coordinate and participate in project meetings, gathering requirements, feedback, and technical comments from stakeholders.
- Support execution, witnessing, and verification of qualification and validation testing activities.
- Ensure all validation deliverables comply with applicable regulatory requirements, industry standards, and site procedures.
- Prepare and maintain accurate documentation records throughout project execution.
- Support Change Control activities, including impact assessments, implementation, and closure of changes affecting qualified systems.
- Collaborate with Engineering, Manufacturing, Quality, Validation, Automation, and Information Technology teams to ensure successful project delivery.
- Identify and escalate project risks, deviations, or issues that may impact qualification activities.
- Participate in deviation investigations, root cause analysis, and corrective and preventive actions (CAPAs) as required.
- Ensure compliance with cGMP regulations and data integrity requirements throughout all project activities.
- Support qualification protocol execution using the Application Lifecycle Management (ALM) platform.
- Maintain effective communication with cross-functional teams and stakeholders in both English and Spanish.C ^&
- Establish, maintain, and enforce document management structures within SharePoint-based document repositories.
- Control and manage commissioning, qualification, and CSV documentation throughout the project lifecycle.
- Upload, retrieve, organize, and maintain documentation within designated electronic repositories.
- Route documents for review and approval through applicable document management systems and workflows.
- Revise documents to incorporate stakeholder comments and technical requirements.
- Coordinate follow-up activities with reviewers and approvers to ensure timely document approval.
- Maintain document accuracy, quality, version control, and compliance with procedural requirements.
- Support management of legacy documentation that requires updates or revisions related to qualification activities.
- Bachelor's degree or higher in Engineering, Computer Science, Chemistry, or a related scientific discipline.
- Experience in pharmaceutical manufacturing environments, preferably within sterile manufacturing operations.
- Hands-on experience in Commissioning & Qualification (C&Q) activities.
- Experience supporting Computer System Validation (CSV) projects.
- Strong knowledge of Change Control processes.
- Strong understanding of cGMP regulations and pharmaceutical compliance requirements.
- Experience writing technical documentation, protocols, reports, and validation records in English.
- Proficiency with Microsoft Office applications.
- Bilingual proficiency in English and Spanish (written and verbal).
- Experience executing qualification protocols within ALM (Application Lifecycle Management).
- Active access and experience utilizing ALM for qualification execution activities is required.
- Attention to Detail
- Project Coordination