Sérfræðingur í staðfestingu fyrir CPV & flutninga / CPV & Transport Validation Specialist

Hefur þú áhuga á því að tryggja gæði og heilindi líftæknivara? Þrífst þú í teymisvinnu innan GxP-stýrðs umhverfis? Við leitum að sérfræðingi í stöðugri ferliverkun (CPV) og flutningsstaðfestingu til að ganga til liðs við teymið okkar og gegna lykilhlutverki í ferilstjórnun í gegnum CPV og flutningsstaðfestingarverkefni.

Umfang Og áByrgð:

• Þróa og viðhalda CPV-áætlunum fyrir líftæknilyf.
• Greina og fylgjast með ferligögnum til að hafa eftirlit með lykilferlibreytum (CPPs) og lykilgæðaeinkennum (CQAs).
• Styðja við rannsóknir, innleiðingu CAPA og ferlabætur.
• Búa til CPV-skýrslur og leggja til í árlegri vöruendurskoðun.
• Vinna náið með framleiðslu, MSAT og QA-teymum.
• Skipuleggja og framkvæma flutningsstaðfestingar fyrir líftæknivörur sem eru viðkvæmar fyrir hitastigi.
• Styðja við staðfestingu flutningsleiða.
• Fylgjast með sendingargögnum og aðstoða við rannsókn frávika.
• Viðhalda staðfestingargögnum í samræmi við GDP og GxP-staðla.
• Samræma við flutningsaðila og birgja.
• Tryggja nákvæma skjalfestingu.
• Styðja við úttektir og leggja til í SOP-skjöl og staðfestingarsniðmát.
• Vinna náið með QA, MSAT, birgðakeðju og ytri samstarfsaðilum.
• Taka þátt í fundum og þjálfunarverkefnum.

NauðSynleg HæFni:

• BS-gráða í lífefnafræði, líftækni, lyfjafræði, verkfræði eða skyldu sviði.
• 3–5 ára reynsla í GxP-stýrðu umhverfi.
• Kunnátta á ICH Q8–Q10, leiðbeiningum FDA/EMA og GDP.
• Grunnkunnátta í tölfræðitólum (Excel, JMP, Minitab) og MS Office.
• Nákvæm vinnubrögð og framúrskarandi samskiptahæfni.

[English]

Are you passionate about ensuring the quality and integrity of biologic products? Do you thrive in a cross-functional, GxP-regulated environment? We’re looking for a CPV & Transport Validation Specialist to join our team and play a vital role in lifecycle management through Continuous Process Verification (CPV) and Transport Validation activities.

Key Responsibilities:

• Develop and maintain CPV plans for biologic drug substances and products.
• Analyze and trend process data to monitor CPPs and CQAs.
• Support investigations, CAPA implementation, and process improvements.
• Generate CPV reports and contribute to annual product reviews.
• Collaborate with Manufacturing, MSAT, and QA teams.
• Plan and execute transport validation studies for temperature-sensitive biologics.
• Support lane qualification, thermal mapping, and packaging validation.
• Monitor shipment data and assist in deviation investigations.
• Maintain validation documentation in line with GDP and GxP standards.
• Coordinate with logistics partners and vendors.
• Ensure accurate documentation of validation activities.
• Support audits and contribute to SOPs and validation templates.
• Work closely with QA, MSAT, Supply Chain, and external partners.
• Participate in meetings and training initiatives.

Qualifications:

• Bachelor’s degree in Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or related field.
• 3–5 years of experience in a GxP-regulated environment.
• Familiarity with ICH Q8–Q10, FDA/EMA guidelines, and GDP principles.
• Basic knowledge of statistical tools (Excel, JMP, Minitab) and MS Office.
• Strong attention to detail and excellent communication skills.

What We Offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be a part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration and inclusion.
• Positive, flexible, and innovative work environment.
• Support for personal growth and internal career development.
• Company social events and milestone celebrations.
• Excellent in-house canteen and coffee house.
• Exercise and wellbeing support for full-time employees.
• On-site shower facility.
• Transportation grant towards eco-friendly modes of travel for full-time employees.
• Internet at home for full-time employees.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.