Project Engineer GxP Environment

Job Description

As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle. Therefore, you stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO. Depending on your role and expertise, you may be asked to provide Quality & Compliance support during audits and inspections, or to join a Sopra Steria validation service team.

As a Project Engineer, you will contribute to various engineering projects. You’ll be responsible for the full project lifecycle of specific installations or equipment: from specification and procurement to installation, validation, and handover to operations. You’ll work in multidisciplinary teams, monitor planning and budget, and ensure safe, compliant, and efficient execution. You’ll also be part of creating technical solutions and be included in the technical follow-up with suppliers.

You take ownership of your scope, communicate proactively with stakeholders, and contribute to continuous improvement.

• Master’s degree in a technical or scientific field (industrial, civil, or bio-engineering)
• Experience in a pharmaceutical and/or GMP environment is a strong asset
• Knowledge of validation processes and sterile production is a plus
• Strong organizational and communication skills
• Ability to work independently and take initiative
• Team player with analytical thinking skills
• Affinity with technical, technological, and process-related aspects
• Flexible and resilient in a dynamic project environment
• Experience in project coordination and contractor management is a plus
• Good command of English is required and Dutch is a plus

We offer a generous employee benefits package that includes:

• A variety of perks, such as mobility options (including a company car), insurance coverage, meal vouchers, eco-cheques, and more.
• Continuous learning opportunities through the Sopra Steria Academy to support your career development.
• The opportunity to connect with fellow Sopra Steria colleagues at various team events.

Sopra Steria is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, ancestry, nationality, color, family or medical leave, gender identity or expression, genetic information, immigration status, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran or military status, race, ethnicity, religion, gender (including pregnancy), sexual orientation or any other characteristic protected by applicable local laws, regulations and ordinances.

We foster a work environment that is inclusive and respectful of all differences.