Sobre o trabalho
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.
Responsibilities:
- 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
Leadership:
- 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
Seja a diferença
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
O que oferecemos?
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.