Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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.
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.
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.
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.
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.
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.
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.
Bachelor’s Degree (or equivalent) in:
Pharmaceutical Chemistry and Technology (FCT)
Chemistry
Biotechnology or related scientific field.
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
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