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Simtra BioPharma Solutions

Sterile injectable drug manufacturing

Projektmanager - Für pharmazeutische Investitionsprojekte

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

About the job

Requirements
  • A bachelor's or master's degree in mechanical engineering, electrical engineering, process engineering, or a comparable discipline.
  • Ideally, several years of experience leading capital-equipment 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.
  • Willingness to take responsibility actively and make decisions.
  • Very good German and English language skills.
Responsibilities
  • Take overall responsibility for compliance with central project parameters of schedule, budget, and quality.
  • Develop a risk-based commissioning and qualification strategy, including factory acceptance testing, site acceptance testing, installation qualification, and operational qualification, with an interface to performance qualification.
  • Manage user requirement specifications, design reviews, risk analyses, design qualification and installation/operational qualification 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, including procurement 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 follow up on all deviations and corrective and preventive actions.
  • Support portfolio and investment planning, including the capital expenditure roadmap.
Desired Qualifications
  • Several years of experience leading capital-equipment 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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