Reynslumikill Framleiðslutæknir / Senior Aseptic Processing Technologist

Gakktu til liðs við framleiðsluteymi hjá Alvotech í Reykjavík! Alvotech starfar í reglubundnu umhverfi þar sem nákvæmni og samviskusemi skipta sköpum. Við leitum að einstaklingum með jákvætt hugarfar, góða aðlögunarhæfni og hæfni til að takast á við áskoranir. Vaktavinna er nauðsynleg og felur í sér dag-, kvöld- og næturvaktir.

Hæfniskröfur

• Að lágmarki 3 ára reynsla í lyfjaiðnaði.
• Góð reynsla af vinnu í A og B vottuðu umhverfi.
• Menntun: BS eða diplóma í tæknigreinum, (t.d. líftækni, verkfræði, lífefnafræði) er kostur en ekki skilyrði.
• Þekking á góðum framleiðslu háttum (GMP) og hæfni til að fylgja verklagsreglum.
• Hæfni til þess að vinna vel í teymi með það markmið að ljúka verkefnum á tilsettum tíma.
• Góð enskukunnátta.

[English]

Overview of Role:
Join the Drug Product Manufacturing Team at Alvotech in Reykjavik! Alvotech operates in a highly regulated environment that requires attention to detail and thoroughness. We're seeking someone with strong leadership skills, a positive attitude, and the ability to adapt to challenges. Working day, evening, and night shifts is required.

Scope and responsibility:

• Work in accordance with cGMP standards across various cleanroom zones (Grade A, B, C, and CNC).
• Be part of a collaborative team working to meet the drug product (DP) manufacturing schedule.
• Serve as a Subject Matter Expert for PAIs, audits and regulatory agency interactions.
• Author, review and approve written procedures, SOPs, deviations, CAPAs and change controls.
• Ensure DP manufacturing area and equipment are in inspection-ready state through interaction with Engineering, Facilities, and EHS.
• Continuously identify opportunities for process improvement and waste elimination to maintain a lean, flexible and agile manufacturing facility.

Job requirements:

• 3+ years in (bio)pharmaceuticals is required.
• Previous aseptic filling experiance is essential.
• Good experience working in grade A and B environment.
• Education: BSc or Diploma in a Technical Discipline (e.g., biotechnology, engineering, biochemistry or related field) is advantage but not a requirement.
• Knowledge of Good Manufacturing Practices (GMP), documentation rules, and an ability to follow the documentation for the execution of batch records, SOPs and work instructions is required.
• Be highly motivated and enjoy keeping a team motivated to complete operations activities in timely manner.
• Proficient English skills, Icelandic language not required.

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.