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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Project Manager for Pharmaceutical Investment Projects

Full-Time
No salary listed
Mid
Bachelor's, Master's
Halle, Germany
In Person
Project & Program ManagementProject Management

About the job

Requirements
  • Bachelor's or master's degree in mechanical engineering, electrical engineering, process engineering, or a comparable field.
  • Ideally, several years of experience leading capital investment or production-facility projects, preferably in pharmaceutical manufacturing or alternatively in chemicals or medical technology.
  • A process-oriented and structured approach to project management.
  • Excellent communication skills and assertiveness.
  • Ability to facilitate large teams and negotiate effectively.
  • Very good German and English language skills.
Responsibilities
  • Take overall responsibility for complex investment projects in a GMP-regulated environment, from concept and planning through procurement, construction, and commissioning to qualified handover to production.
  • Ensure the central project parameters of schedule, budget, and quality are met.
  • Develop a risk-based commissioning and qualification strategy, including FAT/SAT and IQ/OQ, with an interface to PQ.
  • Own URS, design reviews, risk analyses, DQ/IQ/OQ documentation, and GMP-compliant project execution.
  • Ensure Good Engineering Practice and documented traceability throughout all project phases.
  • Manage suppliers, including engineering firms, equipment manufacturers, and construction partners, as well as tendering processes and claim management.
  • Communicate proactively with management, Quality, Production, and international stakeholders.
  • Prepare and conduct project reviews.
  • Ensure smooth project execution, including risk and escalation management.
  • Hand over qualified equipment to Production and track all deviations and CAPAs.
  • Support portfolio and investment planning, including the CAPEX roadmap.
Desired Qualifications
  • Experience leading capital investment or production-facility projects, preferably in pharmaceutical manufacturing, or alternatively in chemicals or medical technology.

About the company

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Simtra BioPharma Solutions

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Simtra BioPharma Solutions is a contract development and manufacturing organization specializing in sterile injectable medicines. It supports pharmaceutical and biotechnology companies with formulation, process development, clinical and commercial manufacturing, filling, packaging and related technical services. Facilities and teams operate under regulated quality systems suited to complex parenteral products. Simtra is a business-to-business manufacturing partner rather than a consumer drug brand, helping sponsors move therapies from development into reliable supply through dedicated production expertise and capacity.

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