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- Aufgaben: Lead technical projects, ensuring compliance and operational improvements in biopharmaceutical manufacturing.
- Arbeitgeber: Join a leading biopharmaceutical company focused on innovation and quality.
- Mitarbeitervorteile: Enjoy competitive pay, career growth opportunities, and a collaborative work environment.
- Warum dieser Job: Make a real impact in the biopharma industry while developing your project management skills.
- Gewünschte Qualifikationen: Degree in relevant field and 5+ years of experience in GMP-compliant projects required.
- Andere Informationen: Ideal for those passionate about engineering and operational excellence.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
Your responsibilities
Project Scope and Strategy Development:
- Define the technical requirements and success criteria for the project, ensuring alignment with GMP standards, operational goals, and compliance expectations.
- Collaborate with stakeholders to integrate operational improvements into the overall project plan.
- Develop a comprehensive roadmap for the project lifecycle, from conceptual design through performance qualification (PQ).
Technical Leadership:
- Act as the primary technical point of contact for the project, ensuring all mechanical adaptations and operational improvements meet required specifications.
- Coordinate with EPCM teams to ensure alignment of engineering deliverables with technical and operational requirements.
- Provide guidance and support to production staff implementing operational improvements.
Quality and Compliance Oversight:
- Ensure that all project activities comply with GMP regulations and internal quality standards.
- Collaborate with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).
Cross-Functional Coordination:
- Liaise with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical adaptations into production.
- Facilitate communication and alignment between the production staff and the EPCM to address any technical challenges or deviations.
Project Execution and Monitoring:
- Monitor the progress of technical and operational activities to ensure milestones are met on time and within budget.
- Conduct risk assessments and develop mitigation plans for potential project roadblocks.
- Provide regular updates and technical reports to project stakeholders.
Testing and Qualification:
- Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
- Oversee and coordinate with validation teams to ensure the effectiveness and reliability of the implemented changes
Your qualifications
- Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
- 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.
- Proven experience working on GMP-compliant projects, including change management and qualification activities.
- Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.
- Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
- Proficiency in project management tools and methodologies.
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Technical Project Manager (LZAJP00004963) Arbeitgeber: Coopers Group GmbH
Kontaktperson:
Coopers Group GmbH HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Technical Project Manager (LZAJP00004963)
✨Tip Number 1
Familiarize yourself with GMP regulations and biopharmaceutical manufacturing processes. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality, which are crucial for this role.
✨Tip Number 2
Network with professionals in the biopharmaceutical industry, especially those who have experience in technical project management. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific projects where you successfully managed technical requirements and compliance. Highlight your experience with commissioning and qualification activities, as these are key aspects of the job.
✨Tip Number 4
Stay updated on the latest trends and technologies in biopharmaceutical manufacturing. Showing that you are proactive about learning can set you apart from other candidates and align with our focus on operational excellence.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Technical Project Manager (LZAJP00004963)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and qualifications required for the Technical Project Manager position. Tailor your application to highlight your relevant experience in biopharmaceutical manufacturing and project management.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience in biopharmaceutical manufacturing, focusing on technical project management and operational excellence. Provide specific examples of GMP-compliant projects you've worked on.
Showcase Technical Skills: Detail your hands-on experience with commissioning, qualification, and validation (CQV) processes. Mention any project management tools and methodologies you are proficient in, as this is crucial for the role.
Tailor Your Cover Letter: Craft a compelling cover letter that addresses how your background aligns with the job description. Discuss your ability to lead cross-functional teams and ensure compliance with GMP regulations, as well as your approach to risk assessment and project monitoring.
Wie du dich auf ein Vorstellungsgespräch bei Coopers Group GmbH vorbereitest
✨Understand GMP Standards
Make sure you have a solid grasp of GMP regulations and how they apply to biopharmaceutical manufacturing. Be prepared to discuss specific examples from your past experience where you ensured compliance in project management.
✨Showcase Your Technical Leadership
Highlight instances where you acted as a technical point of contact in previous projects. Discuss how you coordinated with teams to meet specifications and how you provided guidance to production staff during operational improvements.
✨Demonstrate Cross-Functional Collaboration
Prepare to talk about your experience working with various teams such as operations, maintenance, and quality assurance. Share examples of how you facilitated communication and resolved technical challenges in a collaborative environment.
✨Discuss Project Execution Strategies
Be ready to explain your approach to monitoring project progress and managing risks. Provide examples of how you developed mitigation plans for potential roadblocks and how you kept stakeholders informed with regular updates.
