Irun Program & Project Management Job Listings

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Fill & Finish Project Specialist

**About the role** We are looking for a dedicated and detail\-oriented Fill and Finish Project Specialist to join our growing biopharmaceutical manufacturing team. In this role, you will be responsible for overseeing the execution of critical projects related to aseptic operations for the final formulation, filling, visual inspection, and labeling of gene therapy products under GMP conditions. Your contributions will directly impact the delivery of life\-changing therapies for patients worldwide. **Key Tasks:** * Provide expertise on aseptic filling processes * Track department projects while managing team workload. * Execute business cases to support ongoing initiatives. * Oversee capital projects to ensure the company’s objectives and compliance are met. * Support the production planner in coordinating schedules and resources. * Collaborate with the team to identify continuous improvement activities and implement them effectively. * Manage CapEx and OpEx control processes. * Conduct resource analysis for project requirements. * Ensure the development and implementation of efficient processes * Enhance process performance, reduce costs, and improve overall efficiency * Oversee the preparation of detailed internal project documentation * Collaborate with the Quality Assurance team to prepare for audits and inspections * Manage a large group of internal resources to communicate internal project objectives. * Foster a culture of high\-performance and transparent cross\-functional collaboration. **Key Working Relation:** * Reports functionally to Fill \& Finish Manager * Manufacturing departments * Quality departments * Engineering departments **Skills \& Qualifications:** * University master degree in pharmaceutical sciences, chemical engineering or comparable. * Valuable experience in aseptic Fill and Finish processes. * Proficient in planning tools such as Smartsheet or Planner. * Fluent in English and possess excellent communication skills. * A minimum of 5 years of experience in the pharmaceutical industry. * Strong leadership and analytical skills. * Ability to engage diverse stakeholders in projects and take ownership of issues. * Proven project management skills, with an ability to clearly define objectives and priorities while establishing milestones. * High attention to detail, reliability, and ability to work in highly regulated environment. * Excellent problem\-solving and analytical skills, with a data\-driven approach to decision\-making. * Strong communication and interpersonal skills, with the ability to collaborate effectively across functions. * Company values: Humility, Empathy, Responsibility, Commitment, Teamwork, and Effort. **We Offer:** * A dynamic and collaborative work environment. * Opportunities for professional development and continuous training. * Direct impact on the development of therapies that improve people's lives. * Additional benefits; health insurance, vacation, flexibility, etc. If you are ready to take your career to the next level and make a difference in the world of biotechnology, we would like to meet you!

Pagola Kalea, 7, 20018 Donostia / San Sebastián, Gipuzkoa, Spain

Negotiable Salary