Alvotech hf

Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu. Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar. Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum.

Vinnustaðurinn

Sterility Assurance Specialist

Overview of role:

We are seeking an experienced Sterility Assurance Specialist to join our team. In this role, you will play a key part in ensuring aseptic processing and microbial control strategies across our drug substance (DS) and drug product (DP) manufacturing processes. You will provide subject matter expertise in sterility assurance, support compliance with international standards, and contribute to continuous improvement initiatives.

Key Responsibilities:

Contribute to the documentation and management of microbial control strategies from incoming goods to final product.
Provide oversight and sterility assurance expertise to ensure aseptic processing meets international standards.
Monitor facility and quality systems compliance, develop action plans to address deficiencies, and improve processes.
Lead and support investigations related to environmental monitoring, personnel monitoring excursions, deviations, CAPAs, and complaints.
Collaborate with manufacturing teams on media fill simulations, intervention monitoring, and trending.
Perform quality risk assessments for sterility assurance programs, including aseptic practices, environmental monitoring, sterilization, and aseptic process simulations.
Support internal inspections, regulatory, and client audits.
Author, review, and approve GMP documents such as SOPs, batch records, protocols, and reports.
Act as SME for deviations, CAPAs, and change controls related to sterility assurance.
Train, coach, and mentor less experienced staff in aseptic behaviors and cleanroom practices.
Ensure quality metrics and KPIs are maintained within control for areas of responsibility.

Qualifications:

Education: BSc degree in Pharmacy, Microbiology, or a relevant scientific discipline.
Experience: Minimum 8+ years of direct industry experience in pharmaceutical or biopharmaceutical manufacturing, with strong knowledge of cGMP standards for aseptically produced drug products.
Expertise in sterility assurance, contamination control strategies, and aseptic processing.
Strong understanding of environmental monitoring, gowning regimes, cleaning regimes, and disinfectant efficacy studies.
Experience with regulatory inspections and audit readiness.
Excellent communication, problem-solving, and leadership skills.

Fríðindi í starfi

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.

Auglýsing birt3. september 2025

Umsóknarfrestur16. september 2025

Tungumálahæfni