Validation Specialist III
Validation Specialist III
Posted on :
30-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
30-04-2025
Job Description
Job description:
This position of Validation Specialist III in the Manufacturing Science Technology and Analytics (MSAT) function of M&SV 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 industrial sites. The mission of MSAT is to deliver robust and efficient process & testing with associated knowhow transfer to Manufacturing & Quality Control (QC). MTechs function also provides daily support for manufacturing and QC toward industrial performance excellence.
Responsibilities:
This position of Validation Specialist III in the Manufacturing Science Technology and Analytics (MSAT) function of M&SV 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 industrial sites. The mission of MSAT is to deliver robust and efficient process & testing with associated knowhow transfer to Manufacturing & Quality Control (QC). MTechs function also provides daily support for manufacturing and QC toward industrial performance excellence.
Responsibilities:
- Key contributor for strategy development and of development and process validation related to adjuvant manufacture. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation and investigations. The individual in this position will work with a crossfunctional team from various functions in M&SV to deliver following:
- Write protocols reports procedures and memos as needed to support adjuvant manufacturing activities as they relate to engineering investigational definition development and process validation runs.
- Support 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 of training programs for appropriate audiences.
- Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.
- Assist with assessing existing processes and workflows.
- Translate processes to commercial operations.
- Ownership of equipment unit operations and technology capabilities.
- Communicates findings and proposals to upper management.
- Improve Manufacturing Technology strategic programs by supporting nonconformance 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.
- Write protocols reports procedures and memos as needed to support Adjuvant manufacturing activities related to engineering investigational definition development and process validation runs.
- Support 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 scaleup / scaledown parameters utilizing engineering fundamentals (mixing mass / heat transfer modeling dimensionless parameters etc. and process control strategies.
- 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 within sphere of influence; escalates to functional management when appropriate.
- Fosters relationships with partners and customers in order to achieve technical objectives.
- M&SV 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 values of innovation solidarity confidence respect and integrity and our ways of working (Focus Agility Accountability and Simplicity).
- BS or MS in basic sciences math engineering or pharmacy with 2 years experience in biological processes or analytics in a cGMP environment.
- 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.
- Excellent written and oral communication skills.
- 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 startup qualification and validation is preferred.
- Proficiency with PI.
- Prior experience preparing and executing process performance qualification documents (PPQ) preferred.
Employment Type
Full Time
Key Skills
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