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Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.
We are seeking a dynamic and experienced Senior Project Manager to lead critical CAPEX and technical improvement projects within a GMP-regulated biopharmaceutical environment. This role will blend strategic oversight with hands-on project execution, focusing on EHS improvements, mechanical upgrades, and operational enhancements, including the revamping of high-risk chemical storage infrastructure. The ideal candidate will thrive at the intersection of technical project leadership, regulatory compliance, and cross-functional team collaboration.
CAPEX & EHS Program Management
- Lead the planning and execution of CAPEX projects, starting with the modernization of flammable chemical storage facilities.
- Set up and manage a long-term EHS improvement program aligned with Swiss regulations and internal safety standards.
- Identify safety and compliance gaps in chemical storage and handling, implementing corrective actions across departments.
Technical Project Oversight
- Define and validate technical specifications for equipment and infrastructure upgrades, ensuring alignment with GMP standards and operational needs.
- Coordinate with EPCM contractors, internal engineering, and operational teams to synchronize deliverables and ensure technical integrity.
- Guide commissioning and qualification activities (IQ, OQ, PQ), in collaboration with validation experts.
Strategic Planning & Execution
- Develop comprehensive project timelines, milestones, and risk mitigation strategies from design through final qualification.
- Oversee project documentation (URS, FAT, SAT), budget management (CAPEX/IPEX), and reporting to senior leadership and executive committee.
- Ensure efficient cost control, timely delivery, and high-quality outcomes.
Compliance & Change Management
- Ensure full compliance with GMP, Swiss EHS standards, and internal quality systems.
- Collaborate with Quality Assurance to manage change controls, including drafting and reviewing Technical Change Requests (TCRs) and Change Records (CRs).
Stakeholder & Team Leadership
- Serve as the central point of contact for internal teams, external partners, and regulatory bodies.
- Mentor cross-functional teams in project execution, fostering collaboration between engineering, operations, quality, and maintenance departments.
- Provide technical direction without needing deep specialization, bridging gaps between disciplines (HVAC, utilities, infrastructure, etc.).
Profile Requirements:
Education:
- Bachelor’s or Master’s degree in Engineering (Mechanical, Environmental, Biochemical, or equivalent), Project Management, or related technical field.
Professional Experience:
- 5–8+ years of experience in project management within biopharma, chemical, or related industries.
- Proven track record managing CAPEX projects (up to CHF 10M), ideally with EHS or GMP focus.
- Direct involvement in the commissioning, qualification, and validation of systems/equipment (CQV).
Skills & Competencies:
- Solid understanding of chemical safety, GMP compliance, and EHS regulations in Switzerland.
- Proficiency in project management methodologies and tools.
- Strong analytical, organizational, and problem-solving skills.
- Excellent communication and stakeholder management across all levels.
- Languages: Fluent in German and English; French is an asset.
Key Skills
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