Project Engineer - CAPEX (m/f/d) Visp

HHJ BAU GmbH seeks a Senior Freelance Project Engineer for CAPEX projects in Visp, CH. The role focuses on GMP-aligned technical requirements, full project roadmaps, and mechanical adaptations in a biopharma environment.

This position serves as the primary technical lead for mechanical adaptations and process improvements within a GMP-regulated biopharmaceutical setting. The engineer will define success criteria, manage project roadmaps from concept through performance qualification, and ensure alignment with operational goals and regulatory standards.

Responsibilities

• Establish technical specifications and success metrics that comply with GMP regulations and operational targets.
• Oversee the complete project lifecycle, starting from initial concept design and extending through performance qualification (PQ).
• Serve as the central technical resource for mechanical modifications and process enhancements.
• Guarantee adherence to GMP guidelines and internal quality protocols.
• Coordinate change control procedures in partnership with Quality Assurance.
• Facilitate collaboration among operations, engineering, maintenance, and quality departments.
• Track project advancement, schedules, financials, and critical milestones.
• Perform risk evaluations and apply mitigation measures.
• Direct commissioning and qualification efforts, including IQ, OQ, and PQ.
• Work with validation specialists to confirm the effectiveness and compliance of modifications.

Requirements

• Bachelor's or Master's degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related discipline.
• Demonstrated experience in biopharmaceutical manufacturing or GMP-regulated settings.
• Proven success in technical project management or operational excellence programs.
• Extensive background in GMP processes, change management, and CQV activities.
• Comprehensive knowledge of commissioning, qualification, and validation methodologies.
• Strong project management and organizational abilities to handle multiple workstreams.
• Exceptional problem-solving skills in complex and fast-paced environments.
• Effective communication and stakeholder management capabilities.
• Strong English proficiency is required.

Nice to have

• Fluent German language skills are preferred.

What the company offers

• Chance to contribute to high-impact projects within a GMP-regulated biopharmaceutical environment.
• Involvement in complex, cross-functional projects with strategic importance.
• Access to professional development and continuous learning opportunities.
• A collaborative and international work environment.

About the company

HHJ BAU GmbH maintains close relationships with customers across various industries, offering engineering specialists exciting projects and attractive job opportunities. The company supports candidates throughout the entire process, from the first contact to the first day on the new job.

• Close customer relationships across industries.
• Supportive candidate journey from initial contact to onboarding.
• Collaborative and international work environment.
• Professional development and continuous learning opportunities.