Sr. Validation Scientist (Media Fills, Smoke Studies & Parenteral)- 34486
Sr. Validation Scientist (Media Fills, Smoke Studies & Parenteral)- 34486
Posted on :
16-08-2025
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1 Vacancy
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Job Description
Summary:
Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades replacements and modifications in the laboratory manufacturing or manufacturing support environment.
Functions:
Knowledge:
Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades replacements and modifications in the laboratory manufacturing or manufacturing support environment.
Functions:
- Able to troubleshoot systemic validation issues.
- Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.
- Develops organizes analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
- Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
- Develop validation engineering policies and procedures that affect multiple organizational units.
- Supervise coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
- Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Work with manufacturing process development utilities facilities labs and/or quality assurance in developing requirements and recommendations for large and/or highly complex process system/facility modifications.
- Work with project managers to complete the validation responsibilities of engineering projects within schedule budget and quality constraints.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
- Prompt and regular attendance to the workplace.
Knowledge:
- Advanced validation knowledge (equipment qualification cleaning sterilization).
- Applies extensive technical validation expertise and has full knowledge of other related disciplines.
- Provide technical solutions to a wide range of difficult problems.
- Solutions are imaginative thorough practicable and consistent with organization objectives.
- Exercises considerable latitude in determining technical objectives of assignment.
- Completed work is reviewed from a relatively long- term perspective for desired results.
- Supervision and guidance relate largely to overall objectives critical issues new concepts and policy matters.
- Essential to the completion of broad programs and projects.
- Decisions recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.
- Leads efforts of group of peers directly supervises staff or project resources.
- Guides the successful completion of major programs and may function in a project leadership role.
- May be expected to directly supervise staff or project resources.
- Represents the organization as the prime technical contact on contracts and projects.
- Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
- Understands regulatory trends in industry and able to make connection between those trends and established corporate direction.
- Some direct experience with FDA or equivalent regulatory body.
- Represents the organization as the technical expert to endorse the organizations validation programs and practices.
Education:
- Masters degree and 3 years of directly related experience.
- Bachelors degree and 5 years of directly related experience.
- Microbiology Biology Chemistry Engineering.
Preferred Qualifications:
- Experience in Aseptic Process Simulation (Media Fills) Airflow Visualization Studies (Smoke Studies) Environmental Characterization/Qualification.
- Experience in Parenteral Manufacturing Isolators.
Skills:
- In-depth knowledge of validation processes and requirements.
- Interacts effectively with variety of communication and working styles.
- Ability to independently determine when additional internal resources are required to solve problems.
- Ability to handle multiple projects at one time.
- Demonstrated Skills in the following areas: schedule development facilitation collaboration.
- Basic project management.
- Completion and follow-up.
- Technical expertise areas of validation engineering.
- Ability to independently determine when additional external resources are required to solve problems.
- Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
- Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
- Working knowledge of financial analysis tools.
- Ability to delegate and manage the project work of others.
- Demonstrated Skills in the following areas: Negotiation persuasion and facilitation collaboration project cost development conflict resolution decision making leadership and teambuilding management of contractors and vendors.
Work Methodology:
- 100%-On Site
- 3 months (1st Contract)
- Administrative Shift(weekends and overtime may also be required).
- Professional Service Contract
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
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