Engineer, Validation Operations (12 months assignment)
Boudry, Neuchatel, Switzerland Job Category:
Technical Development Work Location:
Route de Perreux 1 2017 Organization:
Manufacturing Services Employee Status:
Temporary Mission: 12 months
The Validation Operations Engineer performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures. The Validation Operations Engineer has demonstrated experience of managing validation projects, ontime and within budget. They are authorized to direct external vendors performing work in this field.
Duties and Responsibilities
- BS/MS in Engineering/Technical discipline or equivalent experience
- 5 years experience in pharmaceutical Validation or related field
- Familiarity with current international regulatory regulations, cGxP requirements and best
- practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems
- Automation knowledge advantageous
- Communicates pro-actively and collaboratively
- Team player: ability to interact effectively with team and customers
- Good level of English
- Ability to communicate in French is preferred
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- May be assigned Subject Matter Expert role for a defined validation/qualification area.
- Develop and justify the validation approach based on risk and scientific rational
- Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including requirement specifications,
- validation plans, protocols, reports, traceability matrix and summary reports.
- Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.
- Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse/sampling processes.
- Contributes to the development and maintenance of the local site procedures.
- Lead risk assessments and risk management teams
- Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
- Manage validation projects; including managing time, resources and budgets; own associated change controls.
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
- Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation
- Establish and maintain effective relationships with internal team, customers and suppliers.
- Contributes to continuous improvement, including proactively identifying problems and proposing solutions
- Autonomous; completes work independently, seeking guidance on complex tasks and on nonroutine decisions
- Participates in projects and initiatives as directed by their leader
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.