Qualification And Validation – Assistant

Recipharm; Lisboa; On-site; EUR 32,000 - 46,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Growth opportunities

Job summary

GenIbet seeks an Assistant in Qualification and Validation in Lisbon to prepare, review and approve GMP documentation and support the qualification of equipment, systems and utilities. You will handle deviations, CAPAs and change controls, and contribute to clean, auditable records in a fast-paced biopharmaceutical environment.

This role requires a strong foundation in engineering, hands-on execution, and fluent English.

Qualifications

• Bachelor's or Master's in Chemical, Biological, Mechanical or Industrial engineering or related field.
• At least 3 years of experience in the pharmaceutical industry.
• Knowledge of FDA, EMA, GAMP 5, ISPE regulations.
• Experience with qualification of equipment, systems and utilities (HVAC, WFI).
• Fluent in English.
• Team player with strong problem-solving skills.

Responsibilities

• Prepare, review, and approve GMP-related documentation (URS, impact/risk assessment, Master plans, qualification/validation protocols).
• Support the qualification of equipment 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.

Skills

English fluency

Hands-on mentality

Team player

Problem solving

Education

Bachelor/Master in Chemical, Biological, Mechanical or Industrial Engineering

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.