Engineer II, Validation

Description

The work schedule is standard, Monday to Friday.

The role is office-based, with some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs and similar), and adherence to all GMP safety standards.

The company develops scientific solutions for global challenges such as environmental protection, food safety and cancer research.

This Validation Engineer II role supports compliance, quality and operational excellence across facilities through validation activities in pharmaceutical manufacturing, laboratory operations and quality control, working with advanced technologies and diverse teams.

Responsibilities

• Carry out validation activities that keep facilities compliant, quality-driven and running well.
• Support pharmaceutical manufacturing, laboratory operations and quality control with validation work.
• Work with advanced technologies and cross-functional teams to maintain high standards.

Requirements

• Hold a bachelor's degree in engineering, life sciences, chemistry or a related technical field; an advanced degree is preferred.
• Preferably have 2 years of validation experience in a GMP or regulated environment, though this is not required.
• Have run IQ/OQ/PQ protocols, from writing through execution.
• Have managed validation projects on your own.
• Have experience validating automation systems and computer systems.
• Have worked with quality management systems and their documentation.
• Know cGMP, FDA regulations and industry standards such as ISO and GAMP5 well.
• Write clear technical documentation for validation work.
• Assess risk and perform gap analysis with confidence.
• Analyse data and solve problems with strong analytical skills.
• Communicate clearly, both verbally and in writing.
• Use Microsoft Office applications proficiently.
• Understand calibration and metrology principles.
• Work in cleanroom environments when required.
• Collaborate well with others.
• Juggle several projects at once.
• Apply statistical analysis and process control methods.
• Show a consistent record of finishing projects on time in a deadline-driven setting.
• The company cannot offer relocation assistance or visa sponsorship for this role.

Conditions

Standard Monday to Friday schedule.

Office-based work, with PPE such as safety glasses, gowning, gloves, lab coat and ear plugs needed to some degree.

Cleanroom work when required.

Relocation assistance and visa sponsorship are not available.