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Rentschler Biopharma SE

<b>Aufgaben</b> <br><b>Profil</b> <br><b>Wir bieten</b> <b>Advancing medicine to save lives. Together.</b><br> <br> Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.<br> <br> Rentschler Biopharma SE is a leading contract development and . click apply for full job details

Ingenieur (m/w/d) Für Technische Versorgungssysteme

<div></div><div><div><div><div><div><div>locations</div><div>
Milford, MA, United States</div></div></div></div><div></div><div><div><div><div><div>
time type</div><div>
Vollzeit</div></div></div></div><div></div><div><div><div><div>
posted on</div><div>
Heute ausgeschrieben</div></div></div></div><div></div><div><div><div><div>
job requisition id</div><div>
JR2416</div></div></div></div></div></div><div><div><div>
Medizin vorantreiben, um Leben zu sch&uuml;tzen. Gemeinsam.</div><div></div><div><br>
Dank vieler Jahrzehnte Erfahrung und unserer Leidenschaft f&uuml;r das, was wir tun, leisten wir einen essenziellen Beitrag zur weltweiten Verf&uuml;gbarkeit von Biopharmazeutika, auch und gerade f&uuml;r Patienten mit seltenen und schweren Erkrankungen.</div><div></div><div><br>
Rentschler Biopharma SE ist ein f&uuml;hrendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) und ausschlie&szlig;lich auf Kundenprojekte fokussiert. Wir bieten ma&szlig;geschneiderte Full-Service-L&ouml;sungen f&uuml;r die Bioprozessentwicklung und die Herstellung komplexer Biopharmazeutika. Als deutsches Familienunternehmen mit internationalem Footprint und globaler Reichweite verbinden wir Experten, Expertise und langj&auml;hrige Erfahrung, um zusammen mit unseren Kunden beste L&ouml;sungen zu entwickeln.</div><div></div><div><br>
Rentschler Biopharma besch&auml;ftigt rund 1.400 Mitarbeiter und hat den Hauptsitz in Laupheim, Deutschland, sowie einen Standort in Milford, MA, USA. Im Jahr 2024 haben wir uns dem Global Compact der Vereinten Nationen angeschlossen und unterstreichen damit unser Engagement f&uuml;r Nachhaltigkeit.</div><div></div><div><br>
Als unabh&auml;ngiges Familienunternehmen leben wir nach dem Motto: Many hands, many minds &ndash; ONE TEAM! Ein offenes, respektvolles Miteinander pr&auml;gt unsere Arbeitswelt, in der Qualit&auml;tsbewusstsein, Sorgfalt und Verantwortung an erster Stelle stehen. Denn bei aller Vielfalt unserer Talente im Rentschler Team verfolgen wir gemeinsam einen Zweck: Medizin voranzutreiben, um Leben zu sch&uuml;tzen.</div><div></div><div>
Duties and Responsibilities</div><ul><li>
Review and evaluate method validation data in accordance with ICH and other method validation guidelines</li><li>
Preparation and review of cGMP method validation/qualification protocols and reports out of the Quality Control Analytical Development group</li><li>
Preparation, design, and/or review of general Quality Control documents (Test Procedures, SOPs, Assay forms, Document Templates)</li><li>
Collaborate with cross-functional teams to ensure that documents are prepared and reviewed in a timely manner</li><li>
Continuously improve method validation documentation and procedural workflows</li><li>
Other technical writing may be required such as Change Controls, comparability reports, Laboratory Investigation Reports, QC technical reports, and other technical writing tasks as assigned</li></ul><div></div><div>
Qualifications</div><ul><li>
Degree in Biochemistry, Molecular Biology or equivalent STEM degree</li><li>
Years of experience and education (one of the following):<ul><li>
Bachelors degree and 8+ years of related experience</li><li>
Masters degree and 5+ years</li><li>
PhD and 3+ years of experience</li></ul></li><li>
Strong experience with method validation and method transfers for biological products</li><li>
Maintain expertise in method validation requirements with a focus ICH Q2R2 Validation of Analytical procedures. Interpretation of country specific guidelines may be required based on project needs</li><li>
Experience with and technical understanding of multiple assay types including but not limited to Chromatography (RP-HPLC, IEX-HPLC, SE-HPLC, etc.), ELISAs, Capillary Electrophoresis, N-Glycan and peptide mapping analysis</li><li>
Demonstrates the ability to depict or present complex scientific data clearly and concisely</li><li>
Knowledge in biotechnical manufacturing processes as well as current GMP regulations, guidance documents, and industry best practices</li><li>
Understanding of statistical evaluation of analytical data</li><li>
Proficient with Microsoft Office &ndash; Outlook, Word, Excel, PowerPoint</li><li>
Should be detail oriented regarding grammar, orthography, scientific precision and taxonomy, layout, and design</li><li>
The candidate should be self-motivated, accountable, and have excellent organization skills</li><li>
Entrepreneurial mindset, economic and analytical thinking</li><li>
Strong and collaborative communication skills, team spirit, flexibility, and be outcome-oriented</li></ul><div></div><div>
Working Conditions</div><ul><li>
Laboratory and manufacturing clean-room environments working with chemical reagents and processing equipment:<ul><li>
Compliance with Personal Protective Equipment, clean room gowning, and EH&amp;S requirements when appropriate/required</li></ul></li><li>
Normal office working conditions: computer, phone, files, copier</li><li>
Will interact with other people</li><li>
Pace may be fast and job completion demands may be high</li></ul><div></div><div>
Physical Requirements</div><div></div><ul><li>
PPE as required</li></ul></div></div></div><div></div>
<br><div><p>Brauchen Sie Hilfe?</p><div><div><div><div><div>
Wenn Sie Unterst&uuml;tzung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team: <div>welcome@rentschler-biopharma.com</div></div></div></div></div></div></div>

Scientific Technical Writer (Analytical Method Validation)

Join Rentschler Biopharma SE and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Rentschler Biopharma SE

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Ingenieur (m/w/d) Für Technische Versorgungssysteme

Scientific Technical Writer (Analytical Method Validation)