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- Aufgaben: Lead process improvement projects and optimize Fill & Finish processes.
- Arbeitgeber: Join Aristo Group, empowering life sciences with innovative solutions.
- Mitarbeitervorteile: Gain valuable experience in a dynamic environment with potential for growth.
- Warum dieser Job: Make an impact in biotech while working on exciting projects and regulatory challenges.
- Gewünschte Qualifikationen: Degree in biotechnology or engineering; 3-5 years in FF processes required.
- Andere Informationen: Fluency in English and French is a must; contract position with a 12-month duration.
Das voraussichtliche Gehalt liegt zwischen 48000 - 72000 € pro Jahr.
Direct message the job poster from Aristo Group
MSP Lead | MSP Partnering at Aristo Group | Empowering Life Science with the Perfect Match
Job title: MS Process Engineer (Fill and Finish) (m/w/d)
Skills: MS Process Engineer
Start of project: asap
Duration of the project: 12 months
Primary Responsibilities
- Lead process improvement projects and optimize process parameters.
- Ensure process performance using Quality by Design (QbD) and Continuous Process Verification (CPV).
- Address deviations, CAPAs, and conduct product impact assessments.
- Oversee FF process/equipment projects from URS to PPQ.
- Support validation activities and technology transfer.
- Prepare for and participate in regulatory inspections.
Key Activities
- 45% Manufacturing Support: Monitor processes, manage deviations, and ensure compliance.
- 45% Projects: Lead or contribute to FF process improvement and equipment initiatives.
- 10% Regulatory: Address audit and inspection-related tasks.
Qualifications
- Education: Degree in biotechnology or engineering.
- Experience: 3–5 years in FF processes for recombinant protein; cGMP knowledge.
- Languages: Fluent in English and French.
- Skills: Strong statistical analysis, communication, and leadership abilities.
Seniority level
- Associate
Employment type
- Contract
Job function
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MS Process Engineer (Fill & Finish) Arbeitgeber: Aristo Group
Kontaktperson:
Aristo Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: MS Process Engineer (Fill & Finish)
✨Tip Number 1
Reach out directly to the job poster on LinkedIn. A personalized message expressing your interest in the MS Process Engineer position can help you stand out and show your enthusiasm for the role.
✨Tip Number 2
Highlight your experience with Quality by Design (QbD) and Continuous Process Verification (CPV) during networking conversations. This will demonstrate your relevant expertise and align your skills with the job requirements.
✨Tip Number 3
Prepare specific examples of past process improvement projects you've led or contributed to. Being able to discuss these experiences in detail will showcase your leadership abilities and problem-solving skills.
✨Tip Number 4
Familiarize yourself with the regulatory landscape related to FF processes. Showing that you understand the importance of compliance and can navigate audits will make you a more attractive candidate.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: MS Process Engineer (Fill & Finish)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the MS Process Engineer position. Understand the key responsibilities and qualifications required, especially focusing on process improvement and regulatory compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in Fill & Finish processes, particularly any projects related to recombinant proteins and cGMP knowledge. Use specific examples to demonstrate your skills.
Showcase Language Proficiency: Since fluency in English and French is required, make sure to mention your language skills prominently in your application. If you have certifications or relevant experiences, include those as well.
Tailor Your Application: Customize your CV and cover letter to reflect the specific requirements of the job. Use keywords from the job description, such as 'Quality by Design' and 'Continuous Process Verification', to align your application with what the company is looking for.
Wie du dich auf ein Vorstellungsgespräch bei Aristo Group vorbereitest
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with Fill & Finish processes, especially in relation to recombinant proteins. Highlight specific projects where you led process improvements or optimized parameters, and be ready to explain the methodologies you used.
✨Demonstrate Quality by Design Knowledge
Since the role emphasizes Quality by Design (QbD) and Continuous Process Verification (CPV), make sure to articulate your understanding of these concepts. Provide examples of how you've applied QbD principles in past projects to ensure compliance and enhance process performance.
✨Prepare for Regulatory Discussions
Given the importance of regulatory inspections in this role, familiarize yourself with common audit processes and inspection readiness. Be ready to discuss your experience with CAPAs and how you've addressed deviations in previous roles.
✨Highlight Your Communication Skills
Strong communication is key in this position. Prepare to discuss how you've effectively communicated with cross-functional teams and stakeholders in the past. Consider sharing examples of how your leadership abilities have contributed to successful project outcomes.
