The Validation Engineer:New Product Development is responsible for supporting the new product development (NPD) team as they develop, validation and commercially launch new products and novel product presentations. The Validation Engineer - NPD develops qualification / validation documents (e.g. protocols and reports) satisfying internal and external regulatory expectations. He/she perform independent execution of validation activities required for the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.
- Follow the facility validation policy and validation master plan & ensure safe and compliant cGMP operations.
- Interface with operation and serve as validation SME. Learn the procedures, analytics and document any known sensitivity.
- Support the NPD department in the development and implementation of products/presentations for the facility that ensure all aspects of the validation program are maintained in a state of compliance with respect to site and regulatory standards.
- Coordinate department validation activities within the production schedule.
- Develop the protocols for routine and extraordinary qualification, validation, re-qualification and revalidation of equipment and process.
- Support site Process Validation activities including, but not limited to, Aseptic Process Simulations (APS), Process Performance Qualifications (PPQ), Container Closure Integrity Testing (CCIT), etc.
- Conduct training for internal customers on protocols associated with equipment, systems, and processes under validation.
- Perform investigations associated to validation activities (e.g. deviations or OOS during validation studies).
- Perform data analysis, including the use of statistics, and prepare written reports/summaries from validation studies
- Provide technical input and investigation support for production related investigations, ensuring compliance with validated state of the process.
- Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state of the process.
- Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records) ensuring compliance with validated state of the process.
- Interact with other teams including Process Engineering and Support, Development, Operations, QA and Regulatory
- Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
- Foster strong inter-team relationships to achieve common project goals
- Support the tracking of team metrics and manage completion of objectives and projects
- Participate in routine plant operating meetings
- Create an environment of teamwork, open communication, and a sense of urgency
- Support organizational strategic goals and objectives that are linked to the overall company strategy
- Drive strong collaboration within the plant and across the network
- Build trust and effective relationships with peers and stakeholders
- Deliver business results through timely and quality decision making and advice
- Foster a culture of compliance and strong environmental, health, and safety performance
- Promote a mindset of continuous improvement, problem solving, and incident prevention
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Required Competencies: Knowledge, Skills, and Abilities
- Knowledge of cGMP’s and parenteral / biopharmaceutical regulations
- Deep understanding of facility/clean room design, process, equipment, automation, and validation
- Experience with the start-up, validation, and operations of manufacturing facilities
- Hands-on experience with single-use technologies, closed systems, and filling technologies
- Experience working with external parties and/or participating on cross-functional teams
- Possess strong verbal/written communication skills and ability to influence at all levels
- Ability to think strategically and to translate strategy into actions
- Ability to prioritize and provide clear direction to team members in a highly dynamic environment
- Experience with Operational Excellence and Lean Manufacturing
Education and Experience:
- AS, BS degree and/or equivalent experience (science or engineering is preferred)
- 3 or more years experience in engineering & validation of pharmaceutical manufacturing equipment
- Experience participating in regulatory inspections and explaining/defending work
- General knowledge of the injectable pharmaceutical industry, sterile compounding preferred
- Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and industry best practices
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.