Engineer Manufacturing (Packaging/Bulk) Operations
Boudry, Neuchatel, Switzerland Job Category:
Technical Development Work Location:
Route de Perreux 1 2017 Organization:
Manufacturing Employee Status:
Full-time Job Type:
Celgene is committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team. What unique gene will you bring to Celgene?
On the Manufacturing team, we deliver our mission by owning and leading updates of GMP documents related to Packaging Operations. You will initiate and owns deviations related to manufacturing and leads investigation tasks as required. Also you will support the Head of Manufacturing Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training.
As the Engineer Manufacturing Operations (Bulk, Packaging), you'll support that goal by....
- Authoring and reviewing manufacturing (Bulk/packaging) documents, including specification, working practices, Form's, logbooks. Follow up approval flow within electronic documentation system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
- Leading risk assessments and risk management cross-functional teams (from draft to approval).
- Supporting Critical Quality Attributes and Critical Process Parameters definition and implementation.
- Performing complaint investigation.
- Initiating, own and follow up change controls related to manufacturing. Manage stakeholders involved.
- Initiating deviations and participate to or lead on the floor investigations. Partner with QA and Boudry Manufacturing Operations to ensure assessments and investigations are exhaustive.
- Following up and implement assigned CAPA's.
- Contributing to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
- Participating in or lead projects and initiatives as directed by the Head of Manufacturing Operations.
- Acting a quality system and GMP Documentation referee for the Manufacturing Ops Team and as a key manufacturing team representative for QA Ops.
- Supporting the Head of Manufacturing Operations in proactively monitoring Quality and performance metrics and in proposing improvement measures.
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- BS/MS in Engineering/Technical discipline or equivalent experience
- 5 years' experience in pharmaceutical validation, manufacturing or related field
- Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting).
- Knowledge of pharmaceutical facilities, manufacturing (bulk/packaging), and laboratory systems and processes.
- Well-developed ability to constructively work across functional areas and levels to achieve results,
- Strong verbal and written communication skills,
- Strong analytical, problem solving, influential and deductive skills,
- Capability to work with short deadlines and simultaneous activities,
- Excellent organizational and project management skills.
- Fluent in English and in French.
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.