MS&T Specialist I

Job Description

Job 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 Power BI, Power Platform, Python and various presentation tools), JMP, R, etc. is necessary.

Duties and Responsibilities:

• 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.

Education / Certification:

• Requires a college fresh Ph.D. With chemistry.
• Basic certifications in areas of Power Platform, AI, Project Management, preferred.

Knowledge, Skills and 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.