Provide direct support with respect to compliance, regulatory assessment, validation and engineering to the Sterile manufacturing business unit, clients and corporate management. Plan, organize, execute and track multiple tasks of low complexity to ensure timely completion of deliverables related to equipment and process validation. Analyze data for routine validation and production documentation to determine acceptability, identify deviations and make appropriate notification. Prepare documents and reports; gain multidisciplinary consensus with some degree of independence. Maintain and use database systems. Prepare, retrieve and review documentation for customer and regulatory audits. Collaborate with senior personnel to resolve deviations. Assess impact of changes of low complexity. Prepare documents for records archival. Work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Comply with all job-related safety and other training requirements. Perform other duties as assigned.
- Provide direct support with respect to compliance, regulatory assessment, validation and engineering to the Sterile manufacturing business unit, clients and corporate management.
- This is an entry level role supporting high complexity, life-saving products and offers the successful candidate the opportunity to develop a career as a world-class validation professional. The potential candidate should meet one of the following criteria:
- BS in related field (Engineering, Industrial Technology, Computer Science, Chemistry, Biology, or other technical or physical/life science).
- An AAS in related field with two years of relevant experience.
- Three years of relevant experience in related field, including a demonstrated ability to review, revise and perform pharmaceutical procedures associated with validation and resolve issues of low complexity. Eg: Technical support of computer/equipment/process systems, system testing, laboratory testing, technical and scientific writing, interpretation of regulations/guidelines, review/analysis of data, problem resolution.
- Familiarity with the pharmaceutical industry or other regulated industry id preferred Eg: Knowledge of cGMPs and FDA/industry expectations. Must be proficient in the use of computerized office applications (e.g. Word, Excel), project management and demonstrated scientific writing skills.
The Procedure and Contact
DSM's wide diversity of disciplines makes it possible to offer employees a great variety of roles throughout their career. For instance, you may start your career in an area related to your education/qualifications, but your future is what you make of it. At DSM we stimulate people to determine their own career path and we encourage international careers. We strive to be an Employer of Choice and ensure that our employees are nurtured and given the opportunity to develop their talents. To learn more about DSM's HR vision and policy, please visit our website at www.dsm.com/careers
We offer a challenging and rewarding job in an innovative multinational company with several opportunities for personal input and development; an open and dynamic atmosphere; a 'never-stop-learning' attitude. Terms and conditions of employment as well as fringe benefits are market competitive.
Please apply online at www.dsm.com/vacancies. The procedure is in line with what you can expect from an Equal Opportunity Employer. DSM participates in E-Verify.
DSM - 18 months ago
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