Qualification And Validation – Assistant

Gen Ibet; Viseu; On-site; EUR 26,000 - 38,000; Full time

Benefits offered by this job

Competitive salary

Career growth

Collaborative environment

Global projects

Job summary

GenIbet, a cGMP biopharmaceutical CDMO, seeks a Assistant in Qualification and Validation to support documentation, equipment and systems qualification, and change control activities. You will collaborate across Production, QC and Maintenance to ensure compliant, timely deliverables.

Ideal candidates hold a scientific or engineering degree and have hands-on experience in GMP environments, with strong problem-solving and teamwork skills.

Qualifications

• BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering or other relevant area.
• 3 years of experience in the Pharmaceutical Industry.
• Knowledge of industry regulations and standards (FDA, EMA, GAMP 5, ISPE).
• Experience with the qualification of equipment, systems and utilities (HVAC, WFI).
• Fluent in English.
• Passion for hands-on, on-field work.
• Team player.
• Problem-solving and critical thinking skills.

Responsibilities

• Prepare, review, and approve GMP documentation (URS, risk assessments, master plans, qualification/validation protocols).
• Support qualification of equipment and computerized systems.
• Handle Deviations, CAPAs and Change Control activities.
• Create and revise procedures for equipment, facilities and computerized systems.
• Update asset management software.
• Work independently, take ownership to plan and deliver tasks on time.
• Coordinate between Production, QC and Maintenance.

Skills

Fluent in English

Education

BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering or other relevant area

Job description

POSITION NAME QUALIFICATION AND VALIDATION – ASSISTANT COMPANY DESCRIPTION

GenIbet is a cGMP biopharmaceutical CDMO - Contract Development Manufacturing Organization - offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies. GenIbet's core activity is the manufacture and supply of materials for use in early-stage drug development, pre-clinical studies and cGMP manufacturing for clinical trials and commercial.

RESPONSIBILITIES

• Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation protocols)
• Support the qualification of equipment's and computerized systems
• Operational handling of management of Deviations, CAPAs and Change Control activities
• Creation and revision of procedures related to equipment, facilities and computerized systems
• Update of the asset management software
• Self-dependent way of working and taking ownership of assigned task to plan and deliver according to agreed timelines
• Facilitator between different departments: Production, QC and Maintenance

REQUIREMENTS

• BSc or MSc in Chemical, Biological, Mechanical or Industrial engineering or other relevant area
• 3 years of experience in the Pharmaceutical Industry
• Knowledge of industry regulations and standards (FDA, EMA, GAMP 5, ISPE)
• Experience with the qualification of equipment, systems and utilities (HVAC, WFI)
• Fluent in English
• Passion for hands-on, on-field work
• Team player
• Problem-solving and critical thinking skills

OFFERED

• Competitive salary and attractive benefits
• Opportunities for professional growth and development
• Innovative and collaborative working environment
• Participation in challenging projects with a global impact