PSC Biotech Europe is seeking an experienced Senior Project Manager / Scheduler to lead a critical engagement with a major Swiss-headquartered biopharmaceutical company. This role will focus on managing the renovation, qualification, and validation of an aseptic clinical trial manufacturing fill-finish facility with four aseptic filling lines.

The project originated from EU GMP Annex 1 compliance requirements and incorporates Swissmedic feedback to revise people/material flows and enhance aseptic controls. The Senior Project Manager / Scheduler will ensure the timely and compliant delivery of a fully qualified facility, enabling the resumption of clinical trial manufacturing operations.

This is a high-visibility, onsite leadership role requiring technical depth, scheduling expertise, and the ability to proactively resolve issues in a fast-paced environment.

Key Responsibilities:

• Lead the end-to-end project management and scheduling of CQV activities, ensuring adherence to timelines and quality standards.
• Oversee revalidation/qualification of clean utilities, HVAC systems, building automation, and process equipment.
• Manage facility and aseptic process qualifications, including revised material and personnel flows for each filling line.
• Drive compliance with Annex 1 and Swissmedic regulatory expectations.
• Develop and maintain detailed project schedules and Gantt charts to monitor progress and identify risks.
• Collaborate cross-functionally with engineering, validation, QA, and operations teams, as well as external contractors and vendors.
• Communicate project updates, risks, and mitigation strategies to senior leadership and stakeholders.
• Ensure safe, compliant, and efficient execution of all project deliverables.

Requirements & Qualifications:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related discipline.
• 10+ years of aseptic fill-finish experience, with a proven track record in facility renovations, CQV, and regulatory-driven upgrades.
• Strong expertise in EU GMP Annex 1 and aseptic facility operations.
• Demonstrated ability to develop and manage complex project schedules using MS Project, Primavera, or similar tools.
• Exceptional leadership, organizational, and interpersonal skills.
• Ability to work onsite in Switzerland and engage effectively with multinational teams.
• Fluent in English; German or French language skills are advantageous.

What We Offer

• Opportunity to lead a strategic, high-impact project with a global biopharmaceutical client.
• Competitive compensation package.
• Professional development within a global life sciences consultancy.
• A collaborative, innovative, and compliance-driven work environment.
• This is a full-time, onsite role representing PSC EU based in Basel, Switzerland