Engineer, Manufacturing Compliance
1903820 Job Category:
Technical Development Organization:
Manufacturing Employee Status:
Full-time Job Type:
On the Manufacturing Complianceteam, we deliver our mission by owning and leading updates of GMP documents related to Bulk and/or Packaging Operations. You will initiate and own deviations related to packaging and leads investigation tasks as required. You will also support the Head of Bulk and/ or Packaging 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 Compliance, you'll support that goal by....
- Initiating deviations and participate to or lead on the floor investigations. Partner with QA and Boudry/Couvet Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
- Following up and implement assigned CAPA's.
- Authoring and reviewing manufacturing (bulk/packaging) documents, including specifications, working practices, Forms and logbooks. Follow up approval flow within electronic documentations 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 investigations.
- Initiating, owning, and following up change controls related to manufacturing (bulk/packaging). Manage stakeholders involved.
- Contributing to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
- Participating to or lead projects and initiatives as directed by the Head of manufacturing (bulk/ packaging Operations.
- Acting a quality system and GMP Documentation referee for the manufacturing (bulk/packaging Ops Team and as a key Packaging team representative for QA Ops.
- Supporting the Head of Packaging 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, packaging 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, etc).
- Knowledge of pharmaceutical facilities, manufacturing, 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.