Equipment Systems Engineer
4 settimane fa
Catalent Pharma Solutions is seeking a skilled Equipment Systems Engineer to join their team in Anagni, Italy.
This role will focus on managing and collaborating on URS definition, system specification review, and system design with the engineering team and stakeholders.
Key responsibilities include:
- Technical expertise in equipment and systems, with a focus on HVAC.
- Coordinate or collaborate in troubleshooting exercises on equipment and systems, demonstrating the ability to discover potential solutions using technical knowledge.
- Assess situations and create effective solutions to challenges or issues, and propose solutions in a team-working environment.
- Collaborate with site functions according to procedures and directives.
- Manage or collaborate on capital account projects, ensuring compliance with cGMP, within established times and costs, and applicable procedures.
- Constantly maintain communication and coordination with all functions involved to ensure they are updated on projects and their impact.
- Support the technical assessment of the quality and performance of contractors in relation to interventions and requirements requested and associated costs.
- Participate in the technical assessment of new technologies and materials relating to activities connected with capital projects, in collaboration with the team and stakeholders.
- Analyze and close Quality Events resulting from technical causes.
- Ensure all activities are completed in accordance with regulations, site procedures, and company policies, and guarantee compliance with internal and corporate procedures designed in accordance with current regulations, Good Manufacturing Practices, ISO 13485, and CRF 21 part 111.
Desired qualifications and experience include:
- Experience in managing projects and activities, even complex ones, through interactions with functions, and in compliance with provisions on health, safety, and the environment.
- Experience in troubleshooting and problem-solving.
- Advanced knowledge of sterile pharmaceutical systems, particularly vials and PFS Fill & Finish technologies, HVAC, and sterilization systems.
- Specialized degree in Engineering or related subjects with experience in the management of Engineering projects.
- Good knowledge of the English language.
- Advanced knowledge of pharmaceutical systems and their operation.
- Consolidated knowledge of asepsis techniques (sterile area).
Catalent offers rewarding opportunities to further your career, making a difference in people's lives.
Join Catalent, a global company where employees work directly with pharma, biopharma, and consumer health companies to advance new medicines from early development to clinical trials and to the market.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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