Project Engineer, Regulatory Compliance Specialist

This role is responsible for managing a specific project, part of the Site Master Plan (SMP) project ($ 150 - 200MM), working in collaboration with the overall project program lead to ensure project progress throughout the project lifecycle, with a heavy focus on Facility Construction, Commissioning and Qualification and Handover.

An ideal candidate for this role will have good experience of leading all aspects of Project Management end to end in medium to high complexity capital projects. They will also have experience and knowledge of process engineering and product in pharma, consumer or medical devices.

• Strategic Project Leadership & Delivery
• Lead large capital projects across all project phases (planning, design, procurement, construction, commissioning).
• Coordinate multi-functional engineering strategies to meet schedule, budget, quality, and regulatory requirements.
• Technical Authority & Governance
• Act as the senior technical authority, review and approve engineering design changes, and technical submittals.
• Ensure engineering solutions align with J&J standards, industry codes, and regulatory expectations.
• Budget & Cost Management
• Lead multi‑million‑dollar capital budgets for assigned projects, monitor costs, and support procurement and contractor selection and evaluation.
• Participate in contractor bid reviews and support value-engineering decisions.
• Scheduling, Risk & Performance Management
• Lead schedule development and integration with program timelines; identify critical path items and drive mitigation.
• Maintain a proactive risk register, recommend mitigations, and track performance metrics.
• Construction Management & Field Leadership
• Provide senior owner-side engineering oversight during construction and commissioning; ensure contractor performance aligns with design intent and J&J EHS standards.
• Promote a strong safety culture and ensure EHS compliance on site.
• Documentation & Reporting
• Maintain detailed engineering records, design documentation, and as-built information.
• Prepare and present executive-level status updates, technical summaries, and risk briefings.

• Bachelor’s degree in Engineering, Architecture, or Construction Management required;
  Master’s degree preferred.

10+ years of experience leading capital projects, preferably in regulated industries (pharmaceutical, biotechnology, medical device, or similar).

• Demonstrated owner-side engineering leadership and experience working with A&E and Construction Management firms.
• Experience leading multi-discipline teams and collaborating with quality, EHS, operations, and external consultants.
• Strong technical judgment and problem-solving skills.
• Excellent communication and leadership skills for multi-functional and executive interactions.
• Proven track record to lead budgets, schedules, and complex contractor relationships.
• Familiarity with regulatory expectations for facilities in regulated industries.
• Proficiency with project management and engineering documentation tools.

Primary

Location:

Schaffhausen, Switzerland

Less than 10% domestic and international travel.