Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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