Engineering Project Manager – (Filling Lines) Capex - 7037

CTC Resourcing Solutions; Bern; Vor Ort; CHF 140.000 - 200.000; Teilzeit

Zusammenfassung

CTC Resourcing Solutions is seeking an Engineering Project Manager for Fill/Finish capex with a global biotherapeutics client. You will drive local CapEx projects from feasibility through qualification, coordinating cross-functional teams in a cGMP environment.

The ideal candidate has strong process/infra engineering background, German and English fluency, and a proven record in pharmaceutical capital projects.

Qualifikationen

• Swiss/EU citizenship or valid permit required
• Engineering/Business/Life Sciences degree (MS/MBA/BS/BA or equivalent)
• 10 years of capital project management in pharma
• Experience with Annex 1 and filling lines
• Functional knowledge of cGMPs and FDA-regulated facilities
• Excellent understanding of project management principles and lifecycle
• Experience to manage high level project budgets
• Ability to multitask across functions
• German and English proficiency are required

Aufgaben

• Scope, develop, procure, construct and qualify new equipment and facilities to meet production demands
• Lead multi-disciplinary teams through project lifecycle to expand capacity
• Maintain integrated project plans, monitor milestones and budget
• Oversee project risks and mitigation strategies
• Ensure initiatives align with business objectives and regulatory expectations
• Deliver cGMP compliant processes and facilities for FDA/global approvals
• Implement EHS by design in projects
• Generate regular project reports for site senior management and global committees
• Influence teams to collaborate and focus on customer outcomes

Kenntnisse

German language

English language

Project management

cGMP knowledge

Ausbildung

Engineering/Business/Life Sciences degree

Jobbeschreibung

Engineering Project Manager – ( Filling Lines)Capex - 7037

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.

The position holder is responsible and accountable for the delivery of local CapEX-projects in the field of (mainly but not limited on) Fill / Finish from feasibility to planning, execution and qualification/validation within the remit of the global engineering and project delivery (ENG / PD) department.

An ideal candidate is some one who possess strong technical knowledge of process and infrastructure engineering, along with demonstrated expertise in cGxP environment. This person is also fluent in both German and English to effectively communicate with global and local teams within the engineering and project delivery organization. This role is on contract basis until the end of the year.

• Responsible for project activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet facility production throughput demands
• Leads multi-disciplinary Teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements
• Develops and maintains integrated project plans and monitors project activities for adherence to milestone timelines, deliverables and budget against approved plan.
• Maintain oversight on project risks and develops risk mitigation strategies.
• Ensures that initiatives are aligned with the business objectives and strategic philosophy
• Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval
• Responsible for implementing EHS by design principles in the project
• Responsible for generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for site Sr. Management and Global Steering Committees
• Project Teams are responsible for completion of project lifecycle activities through performance qualification
• Influences teams to work collaboratively, to be customer focused and to deliver superior performance through personal leadership abilities, mentoring and effective communication.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Successful studies in Engineering, Business Administration or Life Sciences (MS/MBA/BS/BA or equivalent)
• 10 years of experience in managing capital projects in the pharmaceutical industry
• Ideally experience of Annex 1 and filling lines
• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
• Excellent understanding of project management principles and project lifecycle phases, including knowledge of Validation, CMC and facility regulatory submission requirements
• Experience to manage high level project budgets
• Ability to handle many tasks simultaneously and integrate project planning efforts across functions
• Ability to understand \"the big picture\" and approach problem solving in a proactive team manner
• German is good to have and excellent english communicaton