Validation Specialist II in Swiftwater, PA
- Title: Validation Specialist II
- Code: RCI-07572
- RequirementID: 106935
- Location: Swiftwater, PA 18370
- Posted Date: 03/17/2023
- Duration: 12 Months
- Name:Rajgurusingh Azad
- Email: Rajgurusingh.email@example.com
- Phone: 908-704-8843 ✖ 225
- This position of Validation Specialist II, in the Manufacturing Technology (MTech) function of M&S-V, is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the Client industrial sites.
- The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech’s function also provides daily support, for manufacturing and QC, toward industrial performance excellence.
- Key contributor for strategy development and execution of development and process validation related to viral vaccine manufacture.
- Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
- The individual in this position will work with a cross-functional team from various functions in M&S-V to deliver following:
- Write protocols, reports, procedures, and memos as needed to support viral vaccine drug substance manufacturing activities as they relate to engineering, investigational, definition, development and process validation runs
- Support execution of development and validation related studies.
- Document and interpret study results with recommendations
- Provide technical leadership as an subject matter expert in multiple areas of responsibility
- Develop and execution of training programs for appropriate audiences
- Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
- Provide leadership, including project team leadership, within area of expertise
- Assist with assessing existing processes and workflows.
- Translate processes to commercial operations.
- Ownership of equipment unit operations and technology capabilities. Focusing on Drug Substance equipment such as Single Use Bioreactors, Tangential Flow Filtration units, Chromatography Systems, and Depth Filtration.
- Communicates findings and proposals to upper management.
- Utilizes process simulation software to test and find the most appropriate process strategies.
- Improve Manufacturing Technology strategic programs by supporting non-conformance issues related to change controls, deviations, corrective and preventative actions (CAPAs).
- Participate in Gemba/ shop floor walk through to learn about production processes and / or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
- Develop and update standard operating procedures and related technical documents to align to program strategies under a cGMP environment.
- Work closely with other members of the department to share knowledge and competencies encouraging individual growth and technical contributor.
The Job Responsibilities Include:
- Write protocols, reports, procedures and memos as needed to support viral vaccine drug substance manufacturing activities (upstream processes, downstream purification, products and associated test methods) as they relate to engineering, investigational, definition, development and process validation runs
- Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs.
- Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
- Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment
- Provide technical assistance to manufacturing and quality operations for process troubleshooting improvement, technical transfer and health authority inspections to achieving site metrics (+QDCI).
- Behaves according to company values and competencies.
- Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.
- Effectively communicates successes, constraints, conflicts, solutions and actions for resolution.
- Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.
- Fosters relationships with partners and customers in order to achieve technical objectives.
Who You Are
- Client’s M&S-V mission is to improve worldwide human health, as a reliable manufacturer, by delivering high quality, innovative, and affordable products to our customers.
- You would fit in well with our Client values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).
Education and experience
- BS or MS in basic sciences, math, engineering or pharmacy with 2+ years’ experience or PhD with experience in biological processes or analytics in a cGMP environment.
- Expertise in one or more upstream/downstream process unit operation design typically used in biotech / vaccine manufacturing (seed expansion, viral growth and cell culture egg processes, harvest / clarification, purification, sterile filtration) as well as project / engineering lifecycle.
- Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
- Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
- Experience in equipment start-up, qualification and validation is preferred.
- Prior experience preparing and executing process performance qualification documents (PPQ) preferred.
- Highly motivated.
- Take ownership.
- Biologics experience.
- Statistics mixed with validation (design validation, interpret work).
- Product development experience.
- Understand the processes.
- Drug substance.
- Cell culture.
- Downstream purification.
- Experience isn't as important as the persons desire to take ownership and is motivated. Individual will be validating the process.
- Process Qualification.
- Cross functional.
- Define validation strategies, put it into a protocol, execute protocols and close out protocols with review.
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