Model Risk Analyst III - Validation
M&T Bank$82,783 - $137,972/year
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, ManufacturingIndustries
Requirements
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field
- 2–4 years in equipment validation within a pharmaceutical or regulated manufacturing environment
- Familiarity with finished product manufacturing processes, including automated container handling, powder dosing, and liquid filling
- Strong knowledge of cGMP and FDA guidelines
- Proficiency in protocol writing, execution, and report generation
- Ability to work in cleanroom environments and follow aseptic practices
- Detail-oriented, organized, and excellent communication skills
Responsibilities
- Develop and execute IOQ protocols for manufacturing equipment and automated systems in compliance with cGMP and FDA guidelines
- Perform qualification activities on automated container handling systems, powder dosing equipment, and liquid filling machines
- Document results, manage deviations, and compile final reports in accordance with SOPs and regulatory requirements
- Collaborate with Engineering, Manufacturing, and Quality teams to support equipment qualification and troubleshooting
- Provide technical input during equipment design and change control processes
Skills
IOQ protocols
cGMP
FDA guidelines
cleanroom
automated container handling
powder dosing equipment
liquid filling machines
SOPs
deviation management
equipment qualification
ALTEN Technology
Engineering services for technology and product development
About ALTEN Technology
ALTEN Technology provides engineering services focused on technology and product development across various industries, including aerospace, medical devices, and automotive technology. The company helps clients create advanced products like space exploration tools, medical devices, and autonomous electric vehicles. Their services include agile software development and custom software solutions, which are tailored to meet the specific needs of each client. This collaborative approach aims to reduce risks and ensure successful project outcomes. Unlike many competitors, ALTEN Technology emphasizes a flexible and client-centered model, allowing them to adapt to the unique demands of each project. The goal of ALTEN Technology is to support clients in developing innovative products while securing long-term partnerships through their specialized engineering services.
7830 Thorndike Rd, Greensboro, NC 27409, USAHeadquarters
1988Year Founded
MERGERCompany Stage
Automotive & Transportation, Enterprise Software, Aerospace, HealthcareIndustries
501-1,000Employees