Manager, Quality Engineer
Thermo Fisher Scientific
Monza
20
Scarso
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Azienda: Thermo Fisher Scientific Monza
Esperienza: Esperienza in ingegneria farmaceutica o chimica richiesta
Titolo di studio: Laurea Magistrale in Ingegneria
When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery.
With revenues of more than $40 billion and the most significant investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
SCOPE OF ROLE/RESPONSIBILITY The New Manager will lead the GMP Documentation, Master Batch Record, and Secondary Packaging team that involves the startup a new commercial manufacturing process and technology transfer.
Key Areas of Responsibility: Work with cross-functional teams to drive execution of capex project/tech transfer deliverables and produce required documentation (U Rs, P&Id, trial protocol, etc. ) Lead collaborations with commercial manufacturing and quality to support ongoing qualification activities associated with maintaining a commercial product (new equipment qualifications, etc. ) Be an owner of commercial product(s) and be accountable for Following internal SO Ps and meeting regulatory requirements for the site’s manufactured products.
Collaborate with Production, Technology Transfer, and Quality teams to create and revise the manufacturing instructions.
Handle the master data related to the materials codes and the MB Rs through the PMX system.
Assess the impact of changes on manufacturing instructions Handle minor change requests for the improvement of master batch records Work with a proficient team on the introduction of new products as well as on the modification of documents related to validated products Specific tasks will be tailored to the person’s experience level and abilities Build and lead a team of experts who will work closely together and within a highly matrixed, cross-functional team to successfully deliver business objectives Drive continuous improvement activities and operational excellence Qualifications: Engineering Master’s Degree, pharmaceutical or chemical master degrees with 7+ years of experience Prior experience in developing and/or managing engineers Experience with equipment design, commissioning, troubleshooting, etc for cGMP environment.
Understanding principles for manufacturing combination drug product, and/or pharma batch processes.
Fundamental understanding and application of technology transfer Strong communication (written and verbal), collaboration, and team building skills; ability to connect with all levels of the organization Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Watch as our colleagues explain .
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. # Start Your Story at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
✔ Thermo Fisher Scientific