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
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, ManufacturingIndustries
Requirements
- BS with 2-5 years of relevant experience or MS or PhD in Chemical or Mechanical Engineering or a related discipline
- 2+ years Pharmaceutical Process Development and Validations experience (5+ years preferred)
- Experience with Process Validations, Cleaning Validations, Scale-up, and equipment qualifications
- Experience with performing IQ, OQ and PQ functions for equipment used on different products (tablets, solutions, or topicals)
- Strong Technical writing and documentation skills (cGMP, protocols, reports, OOS investigations, and laboratory notebook documentation)
- Statistical process performance and Project Management (preferred)
- Travel 0-10%
Responsibilities
- Oversee manufacturing equipment and facility commissioning projects including design, selection, and qualification; develop protocols and write reports; write and execute IQ, OQ and PQ protocols against project timelines
- Support project technical development (Manufacturing Controls), from formulations to approval and launch as it applies to project design; work with Formulators during laboratory batches
- Design and perform the execution of sampling and sample preparation in support of cleaning, process, and packaging validation protocols; analyze and review raw data, interpret results, and write final reports
- Manage and monitor assigned product validation projects including cleaning and manufacturing processes; utilize a risk-based approach to establish and maintain the validation program specific to product
- Handle project planning and justification; work with various departments to develop project budgets and timelines; identify and translate priorities into clear, actionable goals and tactics
- Train manufacturing and production personnel on new equipment, cleaning procedures, and manufacturing processes
- Show personal commitment to continuous improvement; accept opportunities that broaden capabilities; apply learnings to improve future experiences
- Other duties as assigned
Skills
IQ
OQ
PQ
process validation
product validation
commissioning
qualification
lean manufacturing
FDA approval
protocol development
data analysis
sampling
sample preparation
manufacturing controls
Pegasus Laboratories
Pharmaceutical products for veterinary industry
About Pegasus Laboratories
Pegasus Laboratories, Inc. specializes in innovative pharmaceutical and medical products for the veterinary industry, including solutions for behavior, urinary incontinence, and seizure management. They operate in a cGMP facility with DEA approval and utilize state-of-the-art manufacturing and laboratory facilities to support their services.
8809 Ely Rd, Pensacola, FL 32514, USAHeadquarters
1986Year Founded
VENTURE_UNKNOWNCompany Stage
Industrial & ManufacturingIndustries
51-200Employees