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
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What are the main responsibilities of the Validation Engineer II role?
The role involves overseeing manufacturing equipment and facility commissioning projects, developing and executing IQ, OQ, and PQ protocols, managing product validation projects, and training personnel on new equipment and processes.
What skills are required for the Validation Engineer II position?
Key skills include effective organization and time management, ability to multi-task and delegate, writing and executing validation protocols (IQ/OQ/PQ), analyzing raw data, and building strong relationships across departments.
What is the company culture like at Pegasus Laboratories?
The company prioritizes people, pets, and the places they go, with a foundation rooted in integrity, innovation, partnership, and pride; as employee owners, they support career and company growth while encouraging continuous improvement.
Is this a remote position or does it require on-site work?
This information is not specified in the job description.
What is the salary or compensation for the Validation Engineer II role?
This information is not specified in the job description.
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