Commissioning & Qualification Specialist
Flexible & Integrated Technical Services View all jobs
- Juncos, PR
- Permanent
- Full-time
- Bachelor’s Degree in Life Science or Engineering and a minimum of five (5) years of experience in the regulated industry.
- Excellent written and verbal skills in both English and Spanish.
- Technical writing skills and problem-solving skills.
- Experience in:
- Drug Substance, Filling, Inspection, and Packaging.
- Facilities and Utilities systems
- Equipment Qualification (IQ/OQ/PQ), Validation Lifecycle Management, and Technical Writing.
- Conceptual Design, Detailed Design, Planning, Execution, and Qualification.
- Lead the drafting, review, and execution of validation protocols, ensuring accurate process documentation and deviation management.
- Apply advanced validation concepts and lifecycle processes to maintain the qualified state of all systems and equipment.
- Provide technical expertise during the conceptual and detailed design phases to ensure validation requirements are integrated from the start.
- Develop and implement validation engineering policies and procedures that impact multiple organizational units and improve site efficiency.
- Coordinate and review the work of a technical staff of engineers and technicians, providing guidance on both an ongoing and project-specific basis.
- Employ advanced validation techniques and ingenuity to develop technical solutions for complex engineering problems.
- Partner with Project Managers to ensure all validation activities are completed within schedule, budget, and quality constraints.
- Develop and manage departmental or project-specific budgets across multiple disciplines for small- to mid-sized projects.
- Lead the planning and scheduling of work activities alongside operations staff to minimize production impact.
- Work closely with Manufacturing, Process Development, Utilities, Labs, and Quality Assurance to develop requirements for highly complex facility modifications.
- Maintain an up-to-date cGMP training status and assist in evaluating maintenance procedures to optimize the overall validation program.