CQV Engineer for Pharma Filling & Packaging Validation

EFOR; Leinster; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

EFOR is seeking a highly motivated CQV Engineer with a strong background in pharmaceutical filling lines to lead commissioning, qualification and validation activities in compliance with GMP and regulatory requirements. You will plan, execute IQ/OQ/PQ protocols for filling line equipment and systems and oversee installation, start-up and troubleshooting to ensure project timelines.

The ideal candidate has a Bachelor's degree or higher in Engineering or Pharmaceutical Sciences, 3+ years CQV

Qualifikationen

• Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, or related field.
• 3+ years’ direct CQV experience in the pharmaceutical industry, with automated filling/packaging lines.
• Proven expertise in writing and executing IQ/OQ/PQ validation documents.
• Strong GMP, FDA, and EMA regulations knowledge as they relate to facility and equipment qualification.
• Experience with risk management, change control, deviation management, and root cause analysis.
• Excellent verbal and written communication skills.
• Ability to work independently and in cross-functional teams.

Aufgaben

• Plan, develop, execute IQ/OQ/PQ protocols for filling line equipment and systems.
• Oversee equipment installation, start-up, and troubleshooting to meet timelines.
• Collaborate with engineering, QA, manufacturing, and project teams to support system integration.
• Prepare and review URS, functional/design specifications, risk assessments, and change controls.
• Ensure all activities comply with SOPs, GMP standards, and regulatory requirements (FDA, EMA).
• Lead investigations into deviations, nonconformances, and CAPA related to qualification/validation.
• Support project management for filling line modification, expansion, or new build projects.
• Provide technical training on validation/qualification processes for staff.

Kenntnisse

CQV

Validation lifecycle

GMP knowledge

Communication

Cross-functional teamwork

Ausbildung

Bachelor’s degree in Engineering

Bachelor’s degree in Pharmaceutical Sciences

Jobbeschreibung

EFOR is seeking a highly motivated CQV Engineer with a strong background in pharmaceutical filling lines to lead commissioning, qualification and validation activities in compliance with GMP and regulatory requirements. You will plan, execute IQ/OQ/PQ protocols for filling line equipment and systems and oversee installation, start-up and troubleshooting to ensure project timelines.

The ideal candidate has a Bachelor's degree or higher in Engineering or Pharmaceutical Sciences, 3+ years CQV