Senior Project Manager Scheduler – Aseptic Fill-Finish Facility
Senior Project Manager Scheduler – Aseptic Fill-Finish Facility
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5years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
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
Bachelors or Masters 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.
Benefits
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 repreeenting PSC EU based in Basel Switzerland
Required Skills:
Qualifications Bachelors or Masters 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.
Employment Type
Full Time
