Celgene is a global biopharmaceutical company 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 skill sets 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 Compliance team, 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.
Skills / Knowledge Required
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.