Specialist – Engineering & CSV Compliance

Overview of role: Join our newly formed team within the Quality division at Alvotech, a leading biosimilar pharmaceutical company. As a Specialist in Engineering & CSV Compliance, you will collaborate with various departments to oversee qualification and validation activities for facilities, utilities, and equipment. You will serve as a Quality representative and subject matter expert, ensuring compliance with EU and US legislation for parenteral manufacturing. Your role will involve supporting QA oversight, reviewing and approving qualification documents, change controls, deviations, and CAPAs, and contributing to investigations and corrective actions.

We seek a candidate with a bachelor's degree in a relevant area, at least 3 years of experience in the pharmaceutical or medical device industry, and a strong understanding of GAMP 5 guidelines. Key Responsibilities: Accountable for completing own tasks or assignmentsReceives assignments from a leader or senior colleaguePerforms mostly routine tasks within procedures and processes but occasionally non-routine tasksChallenges and decisions are discussed, made and solved in cooperation with supervisor or other employeesCan make adjustments or changes to procedures, processes and (occasionally) projects.

Advanced knowledge within field of expertise such as methods, techniques and equipment as well as relevant procedural/process knowledge (SME)Main scope is local or internal that can require immediate or urgent expert attentionQualifications: A bachelor’s degree within relevant area, or other relevant business experienceOngoing relevant courses and training activities. Minimum 3 years of experience within the pharmaceutical or medical device industryMinimum 2 years Quality Assurance experienceExperience working with regulatory requirements in GxP requiredGood understanding of GAMP 5 guide required. Knowledge of and experience with validation and qualification specifically within facility, utility, and equipmentWhat 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 AlvotechAt 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.