MS&T Specialist I
MS&T Specialist I
Posted on :
02-10-2025
Employer Active
1 Vacancy
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Job Description
Description:
Opening: 1
Pay Rate: Confidential Bill Rate: Confidential
Shift Schedule: Monday - Friday 8 am 5 pm
Temp to Perm role: Possibility based on workers performance and openings
Duration: 1 year contingent assignment
Core essential skill sets candidates must have to be considered for the role:
1. College fresh PhD with chemistry
2. Basic certifications in areas of Power Platform AI Project Management preferred
POSITION SUMMARY
This position is responsible for performing activities related to critical aspects of products and processes with focus on process engineering.
Maintains expertise related to process engineering and chemistry is necessary
Digital literacy including basic knowledge of AI (working knowledge of PowerBI Power Platform Python and various presentation tools) JMP R etc. is necessary.
ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
Coordinate manufacturing of batches if required and prepare technical reports.
Performing continuous process and cleaning verification statistical assessments and trend analysis for the development and commercial products.
Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs).
Provide Technical assessments/ product impact assessment summaries on time to avoid back-order situation.
Execute the experimental and process confirmation studies in coordination with planning manufacturing quality LTS and PM groups.
Review and analysis of the analytical and statistical data to support the pre-validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.
Supports pre-validation commercial scale report that includes detailed summary of the equipment and qualified equipment parameters (QEPs) assessment CPPs and CQAs identified during pre-validation work.
Participation in internal (Corporate and QA audits) and external (FDA MHRA) audits.
Remediation of the audit related observations (if any) and timely completion of the action items (if any)
Maintenance of appropriate documentation of protocols reports and laboratory notebooks as required by Standard Operating Procedures (SOPs) and internal policies.
Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
Leading multiple new product introduction site transfer projects and cleaning validation activities.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures Good Manufacturing Practices (cGMP s) and Standard Operating Procedures (SOP s) and Batch Record instructions.
Responsible for performing additional related duties as assigned.
POSITION REQUIREMENTS
Any equivalent combination of education training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
Requires a college fresh Ph.D. With chemistry
Basic certifications in areas of Power Platform AI Project Management preferred
Skills/Knowledge/Abilities:
Ability to prepare various types of complex high quality technical documentation (Batch Records (BR) Change Controls (CC) protocols summary reports technical assessments validation reports and deviation/investigation reports etc.
Ability to handle multiple projects duties and assignments.
Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
Pay Rate: Confidential Bill Rate: Confidential
Shift Schedule: Monday - Friday 8 am 5 pm
Temp to Perm role: Possibility based on workers performance and openings
Duration: 1 year contingent assignment
Core essential skill sets candidates must have to be considered for the role:
1. College fresh PhD with chemistry
2. Basic certifications in areas of Power Platform AI Project Management preferred
POSITION SUMMARY
This position is responsible for performing activities related to critical aspects of products and processes with focus on process engineering.
Maintains expertise related to process engineering and chemistry is necessary
Digital literacy including basic knowledge of AI (working knowledge of PowerBI Power Platform Python and various presentation tools) JMP R etc. is necessary.
ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
Coordinate manufacturing of batches if required and prepare technical reports.
Performing continuous process and cleaning verification statistical assessments and trend analysis for the development and commercial products.
Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs).
Provide Technical assessments/ product impact assessment summaries on time to avoid back-order situation.
Execute the experimental and process confirmation studies in coordination with planning manufacturing quality LTS and PM groups.
Review and analysis of the analytical and statistical data to support the pre-validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.
Supports pre-validation commercial scale report that includes detailed summary of the equipment and qualified equipment parameters (QEPs) assessment CPPs and CQAs identified during pre-validation work.
Participation in internal (Corporate and QA audits) and external (FDA MHRA) audits.
Remediation of the audit related observations (if any) and timely completion of the action items (if any)
Maintenance of appropriate documentation of protocols reports and laboratory notebooks as required by Standard Operating Procedures (SOPs) and internal policies.
Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
Leading multiple new product introduction site transfer projects and cleaning validation activities.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures Good Manufacturing Practices (cGMP s) and Standard Operating Procedures (SOP s) and Batch Record instructions.
Responsible for performing additional related duties as assigned.
POSITION REQUIREMENTS
Any equivalent combination of education training and/or experience that fulfills the requirements of the position will be considered.
Education/Certification/Experience:
Requires a college fresh Ph.D. With chemistry
Basic certifications in areas of Power Platform AI Project Management preferred
Skills/Knowledge/Abilities:
Ability to prepare various types of complex high quality technical documentation (Batch Records (BR) Change Controls (CC) protocols summary reports technical assessments validation reports and deviation/investigation reports etc.
Ability to handle multiple projects duties and assignments.
Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
Additional Details
- Managers Requested Bill Rate : (No Value)
- Shore Options Available for this Position : Onshore Only
- Critical Position : No
- Is this an IT position : No
- Does the position allow for the worker to be virtual/remote : No
- Shift Type : Morning
- White/ Blue Collar Worker : White Collar
- Is this request considered Top Management (Level 3 and up) and management support : Unknown
- Will this position have access to highly sensitive information : Yes
- Will this position have access to sensitive assets (controlled substances narcotics etc.) : Unknown
- Is this a Purchasing/procurement position : Unknown
- Project Code : (No Value)
Employment Type
Full-time
Key Skills
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