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).
* 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 French and English; German is an asset.
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