Staff Eng Project Engineering

360Pharma; Netherlands; On-site; EUR 70,000 - 100,000; Full time

Job summary

360Pharma is seeking a Staff Project Engineer to lead complex pharma engineering projects from feasibility to closure, aligning with GXP and regulatory requirements. You will coordinate across disciplines, manage external partners, and deliver robust engineering solutions.

Required is a engineering or life sciences degree with 7–9 years in multidisciplinary settings, plus SAP and MS Office proficiency. Dutch/EU standards knowledge is vital.

Qualifications

• This role requires strong project management and cross-disciplinary teamwork.
• Experience with GXP requirements and regulatory standards.
• Proficiency in SAP and engineering tools.

Responsibilities

• Lead engineering projects from feasibility to closure.
• Coordinate with internal and external stakeholders.
• Develop technical specs, reports, and presentations.
• Ensure design and changes comply with Dutch/EU standards.

Skills

Project management

Cross-disciplinary teams

GXP compliance

SAP

Education

Bachelor degree in Engineering or Life Sciences

Tools

MS Office

Job description

Job Description

The Staff Project Engineer plays a critical role in managing, leading, and executing complex engineering projects or part of the scope, ensuring alignment with corporate goals, customer requirements, and regulatory standards such as GXP. The engineer combines technical expertise with project management skills to deliver innovative solutions, oversees project lifecycles from feasibility to closure, and support continuous improvement within multidisciplinary teams.

Essential Job Duties and Responsibilities

This position can perform two different roles in projects:

Lead Engineer:

• Acts as Core Team Member in high complexity projects, representing all engineering disciplines and coordinating the complete engineering scope with other involved engineers.
• Provides technical support for project planning, development, implementation, and modification.
• Develops and reviews technical specifications, reports, proposals, and presentations.
• Exercises independent judgment on significant details of work and makes selections and adaptations of engineering alternatives.
• Performs work which involves complex conventional types of plans, investigations, surveys, structures, or equipment with highly complex features for which there may be no precedents.
• Translates scope into request for quotation packages.
• Performs applicable GXP requirements (e.g. Change Control).
• Checks and approves drawings and calculations for design or construction and verifies that design is in-line with the Dutch, European and Janssen Biologics standards.
• Manages progress and quality with external engineering firms, on site contractors and internal stakeholders.Coordinates modifications with stakeholders and participates in Management of Change to ensure proper implementation.

Minimum Qualification

• University / Bachelor or equivalent degree in Engineering or Life Sciences.
• 7-9 years of experience in a multidisciplinary environment
• Experience managing complex projects with cross-disciplinary teams.
• Proficiency in MS Office, SAP, and other relevant engineering tools.
• Strong analytical skills to identify gaps, troubleshooting issues, and develop solutions.
• Ability to work independently with minimal supervision and meet tight deadlines.
• Excellent verbal and written communication skills.

Other requirements

• VCA-VOL Qualification (Diploma)
• Workable knowledge on Eudralex Annex 1 application

Preferred Skills

• Coaching, Collaboration, Corrective and Preventive Action (CAPA), Critical Thinking, Customer Centricity, Feasibility Studies, Lean Supply Chain Management, Organizational Project Management, Problem Solving, Project Engineering, Quality Assurance (QA), Regulatory Compliance, Relationship Building, Science, Technology, Engineering, and Math (STEM) Application, Scientific Research, Supply Planning, Technologically Savvy