#PolpharmaBiologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
- Define automation strategy for Polpharma Biologics
- Manage the portfolio of works associated with the automation function
- Fully accountable of all the assigned assets performance, reliability, safety and compliance
- Partner with other functions to provide the necessary process controls assets life cycle
- Owned the process controls systems and provide technical support with respect to process and infrastructure equipment and systems
- Fulfill all relevant external and internal compliance, EHS and quality requirements
- Develop the automation team to make sure that all reports can fulfill their assigned functional goals and KPIs
- Lead and coordinate the quality processes related to automation team and ensure timely creation, analysis and closure of tasks (Deviations, CAPA, Change Controls) assigned to site Engineering Department with special focus on achieving the site operations quality KPIs
- Execute selection and manage service contractors and suppliers
- Develop and maintain SOPs for control systems within utility, GMP and non GMP areas,
- Provide technical expertise to enable rapid trouble shooting and in depth investigations relating to and system controls performance and operation to maintain and improve asset availability and reliability
- Manage the technical documentation related to automation function
- Provide technical support for projects
- Ensure that automation related operation and maintenance procedure / activities are established and maintained in alignment with all Quality & EHS Systems and Policies, Legal & Regulatory Requirements
- Prepare, update and manage the assigned cost center budgets
- Cooperate with the Technical Operations and all Support Groups to ensure the fulfillment of all plant goals
- Represent the Engineering Department in all internal and external audits
- Diploma in a relevant Engineering Discipline – Automation Field preferred
- > 5 years hands-on equipment or systems experience in a cGMP manufacturing environment
- > 5 years proven managerial experience within process automations or equivalent engineering areas, leading technical and professional resources
- Experience of working with Computerized Systems Validation, eCompliance and in cGMP environment
- Excellence in systematic trouble shooting and problem solving skills
- Technical knowledge and experience in automation systems with preferred exposure in GMP systems, plant maintenance or facilities management
- Thorough knowledge of current Good Manufacturing Practices (cGMP), GAMP, 21CFR Part 11, Annex 11
- Fluent English
- Conceptual and analytical thinking
- Team spirit, dynamic and self-assured behaviour with strong social competence
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.