**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Summary**:
The Process & Cleaning Validation Specialist II independently manages validation and continued process verification activities for sterile manufacturing processes, cleaning procedures, and aseptic process simulations (APS/Media Fill). The role ensures full lifecycle process validation (Stage 2 - Process Qualification and Stage 3 - Continued Process Verification) and guarantees maintenance of the validated state through data-driven monitoring and proactive risk management, in compliance with GMP and regulatory requirements. The Specialist II operates autonomously within assigned projects and acts as a technical reference point for validation topics within cross-functional teams. **Key Responsibilities**:
**Validation Strategy & Technical Assessment**: - Independently analyze technical documentation related to manufacturing processes and cleaning procedures.
- Identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) and define risk-based validation approaches.
- Perform and update risk assessments related to cross-contamination and process robustness.
- Define revalidation strategies and ensure maintenance of the validated state. **Protocol Development & Ownership**: - Independently draft and manage Validation Protocols
- Define sampling plans, acceptance criteria, and statistical methodologies.
- Coordinate cross-functional contributions (i.e Manufacturing, QA, QC, Engineering,).
- Ensure alignment with company procedures and regulatory expectations.



**Process Validation Lifecycle Management**: - Lead execution of Stage 2 Process Qualification (PPQ) activities.
- Establish and manage Stage 3 Continued Process Verification (CPV) programs,
- Provide technical support in deviation investigations related to validation and CPV activities.
- Provide technical guidance to operational departments during validation execution.
- Ensure maintenance of the validated state through continuous monitoring. **Field Execution & Operational Support**: - Actively follow validation activities in the manufacturing area, ensuring proper protocol execution and GMP compliance.
- Be present during critical validation phases
- Provide real-time technical support to operations during validation activities.
- Availability to work on shifts and during weekends/holidays in exceptional cases, depending on production and validation needs. **Data Analysis & Reporting**: - Perform statistical analysis of validation and CPV data.
- Critically evaluate process capability and robustness.
- Independently draft Validation Reports and CPV Periodic Reports.
- Ensure proper archiving and maintenance of validation lifecycle documentation.



**Quality & Regulatory Compliance**: - Ensure compliance with GMP standards and lifecycle validation principles (FDA/EMA guidance).
- Act as validation Subject Matter Expert (SME) during audits and inspections.
- Proactively identify compliance risks and propose mitigation actions. **Education**:
Bachelor’s Degree (or equivalent) in: - Pharmaceutical Chemistry and Technology (FCT)
- Chemistry
- Biotechnology or related scientific field. **Technical Competencies**: - Advanced knowledge of Process Validation lifecycle (Stage 2 & Stage 3 - CPV)
- Experience with Continued Process Verification and statistical trending
- Cleaning validation and contamination control strategy
- Risk management methodologies (FMEA, risk-based validation)
- Solid understanding of EU and FDA GMP requirements for sterile products
- Project management capabilities
- Advanced Excel skills for data analysis **Professional Experience**: - Minimum 3-5 years of experience in Process & Cleaning Validation within sterile pharmaceutical manufacturing.
- Proven experience in: - Sterilizing filtration and filter validation
- Aseptic liquid filling in vials and pre-filled syringes (PFS)
- Validation of lyophilized products in vials
- CPV program management
- Experience working in manufacturing environments during validation execution.
- Equivalent combinations of education, training, and relevant experience may be considered.
- Preferably able to commute to the workplace by own vehicle

📌 Process & Cleaning Validation Specialist Ii (Ferentino)
🏢 Thermo Fisher Scientific
📍 Ferentino