Job Description

Summary:

Commissioning and Qualification (C&Q) contracted services to support capital projects for the Engineering department of a pharmaceutical manufacturing industry in Puerto Rico. Develop the periodic review program and provide periodic review support for GMP-qualified equipment, facilities, and utility systems. This is a key role in maintaining a state of control, ensuring regulatory compliance, and enhancing the effectiveness of the qualification lifecycle management program through expert technical and compliance support.

Responsibilities: Periodic review of GxP systems

Program Development

• Assess existing qualification lifecycle management procedures, standards, templates, and governance processes related to periodic reviews.
• Develop a risk-based periodic review program for qualified direct impact equipment, facilities, and utility systems.
• Establish criteria for asset classification, review frequency, review scope, and approval requirements based on system criticality and regulatory expectations.
• Create standardized procedures, work instructions, templates, checklists, and report formats to support consistent execution of periodic reviews.
• Develop an asset inventory and periodic review schedule for all direct impact systems within the qualification program.
• Define key performance indicators (KPIs), compliance metrics, and program governance requirements for monitoring periodic review effectiveness.
• Establish processes for escalation, risk assessment, gap identification, and remediation of findings identified during periodic reviews.
• Interface with Quality, Engineering, Validation, Facilities, Manufacturing, and System Owners to ensure alignment on program requirements and responsibilities.
• Support implementation of the program through stakeholder training, process deployment, and transition to routine operations.

Program Execution

• Perform periodic reviews of qualified direct impact equipment, facilities, and utility systems in accordance with the approved schedule.
• Coordinate review activities with system owners, subject matter experts, Quality Assurance, and other stakeholders.
• Evaluate the continued qualified state of assets through review of qualification, validation, and lifecycle management documentation.
• Review and assess changes implemented since the previous periodic review, including change controls, assessments, and approvals.
• Analyze deviations, investigations, CAPAs, out-of-specification events, excursions, alarms, and other quality events for potential impacts to system qualification status.
• Review preventive maintenance, corrective maintenance, calibration, and operational performance records to verify continued system reliability and control.
• Evaluate utility and facility monitoring data, environmental monitoring trends, and critical process parameter performance where applicable.
• Assess system compliance with user requirements, design intent, regulatory commitments, and internal procedures.
• Identify qualification gaps, compliance risks, adverse trends, and opportunities for continuous improvement.
• Conduct documented risk assessments to determine whether requalification, additional testing, or corrective actions are required.
• Prepare and issue comprehensive periodic review reports documenting scope, data reviewed, findings, conclusions, and recommendations.
• Present review outcomes and recommendations to Quality, Validation, Engineering, and System Owners for approval and action.
• Track and support closure of resulting actions, CAPAs, and remediation activities.
• Maintain periodic review metrics and provide routine status reporting on program execution, schedule adherence, and compliance performance.
• Support regulatory inspections and audits by providing periodic review documentation, program metrics, and evidence of ongoing qualification lifecycle management.

Requirements:

• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• 3-5 years’ experience in pharmaceutical or regulated manufacturing environment; ideally, the candidate will have previous Oral Solid Dose (OSD) manufacturing experience.

Work Methodology:

• Professional services agreement (independent contractor)
• Full time job
• Full on site job in Vega Baja, Puerto Rico
• Languages: Spanish and English
• Type of industry: Pharmaceutical
• Expected hiring date: October 2026
• Project term: 12 months with potential extensions
• Amount of openings: 2
• Administrative shift, wiling to support non-admin hours