Process Scientist

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Job Description

Previa verifica dei requisiti professionali, costituisce titolo preferenziale l’appartenenza alle Categorie Protette ai sensi dell’art 1 L. 68/99 e/o alle categorie di lavoratori che risultino percettori di interventi a sostegno del reddito e/o risultino disoccupati a seguito di procedure di licenziamento collettivo e/o lavoratori delle aziende del territorio di riferimento coinvolte da tavoli di crisi attivi presso il MIMIT.

OBJECTIVES/PURPOSE :

• Authors, issues, and maintains PPQ protocols, PPQ reports, and supporting validation studies (eg. Mixing, process and hold times, lifecycle qualification) in alignment with internal procedures and regulatory expectations.

• Defines and supports process validation strategies across lifecycle stages, including qualification rationale, study design, and acceptance criteria.

• Supports evaluation of process changes impact, deviations, and improvement initiatives on validation status and continued process verification.

• Supports Compliance and Regulatory affairs department during preparation and update of regulatory documentation (as far as it is within its competence)

• Supports inspection readiness and contributes to internal/external audits and regulatory documentation, as applicable

ACCOUNTABILITIES :

• Authors, revises, and issues PPQ protocols, PPQ reports, and supporting validation studies (e.g., mixing studies, hold time studies, lifecycle qualification documents).

• Contribute to validation strategies definition and study approaches based on process knowledge, product requirements, quality risk management, and regulatory expectations.

• Establishes scientific rationale, critical process parameters, critical quality attributes, acceptance criteria, and sampling plans for validation activities.

• Coordinates cross-functional input and alignment with Manufacturing, QA, QC, Regulatory Affairs, Compliance, and other technical functions during preparation and execution of validation documentation.

• Assesses the impact of process changes, deviations, CAPAs, and investigations on validated status and identifies any need for requalification or additional studies.

• Supports execution oversight of PPQ and validation-related studies, including data review, technical interpretation, and final reporting.

• Contributes to process monitoring, trending, continued process verification, and identification of process robustness or yield improvement opportunities.

• Supports risk assessments (e.g., PFMEA or equivalent) related to process validation, process changes, and lifecycle management.

• Provides technical support during audits, inspections, and preparation of validation-related regulatory documentation and responses.

• Support in maintaining the GMP archive for the group, including responsibility of document withdrawal and destroy.

CORE ELEMENTS RELATED TO THIS ROLE:

• Good scientific and technical writing skills, with the ability to translate process knowledge into clear, compliant validation documentation.

• Risk-based mindset with the ability to define pragmatic and scientifically sound validation strategies.

• Problem-solving, and critical-thinking capability.

• Ability to work effectively across functions and align stakeholders on validation approaches and technical decisions.

• Good understanding of lifecycle validation, QbD principles, and regulatory expectations

Technical/Functional (Line) Expertise

• Good knowledge of process validation lifecycle principles, including process design, PPQ, and continued process verification.

• Experience in plasma fractionation processes or in biotechnology field. Strong Knowledge of GMP

• Good Knowledge of risk management tools and application to validation strategy (e.g., PFMEA, impact/risk assessments).

• Experience in authoring technical documents such as protocols, reports, assessments or validation studies.

• Ability to interpret process data, statistical outputs, and manufacturing trends to support technical conclusions and validation decisions.

• Fluent Italian and English, both written and spoken

Leadership

• Demonstrates ownership and accountability for assigned validation activities and deliverables.

• Influences cross-functional teams through technical expertise, clear communication, and sound scientific rationale.

• Prioritizes effectively and delivers high-quality outputs within agreed timelines.

• Promotes collaboration, continuous improvement, and a compliant, inspection-ready mindset.

• Acts with integrity and in alignment with company values and patient focus.

Decision-making and Autonomy

• Define Process validation Strategy

• Evaluates the Impact of events and appropriately escalate topics with high criticality

• Develop and execute process validation concepts in compliance with external and internal requirements and state of the art expectations

Interaction

• Works closely with Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Compliance, Engineering, and global / local MSAT and process stewardship teams.

• Collaborates with cross-functional stakeholders to align validation strategy, documentation content, execution planning, and issue resolution.

• Provides technical input and communicates validation rationale clearly to both local and global stakeholders.

Innovation

• Apply scientific knowledge and critical thinking to improve validation approaches, process understanding, and lifecycle management.

• Identifies opportunities to simplify, standardize, and strengthen validation documentation and study design.

• Promotes data-driven decisions and continuous improvement in process validation practices.

Complexity

• The role operates in a complex GMP environment requiring integration of scientific, operational, quality, and regulatory considerations.

• The role manages multiple validation topics simultaneously, often with cross-functional dependencies and changing priorities.

• Requires balancing compliance expectations, technical rigor, process performance, and operational feasibility.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Master or PhD degree in technical / scientific education, preferably pharmaceutical sciences, chemistry, biochemistry, biotechnology or pharma - process engineering

ADDITIONAL INFORMATION:

• Willingness to travel occasionally for internal/external meetings, as required.

Locations

ITA - Rieti

Base Salary Range:

€31,200.00 - €42,900.00

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time