LC01-120721 - Sr Quality Validation Engineer
Job Posting for LC01-120721 - Sr Quality Validation Engineer at Validation & Engineering Group
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking for talented, dedicated individual who is committed to work under the highest standards of ethics to and with expertise in the following area:
- Quality / Validation Engineer
Scope:
-
Support new and transferred products by leading efforts of implementation of methods and procedures for inspecting, testing, and evaluating product including executing line trials, process risk analysis; and participating in design and process validations to determine appropriate sampling plans for validations and routine production.
-
Design, plan, write protocols, execute, document results, writes reports, and gain the required approvals for all validation activities. Validation activities include, but are not limited to product processing, product packaging, Cleaning (TOC and Recover), and utilities.
-
Collaborates with Operations, Engineering, and R&D and manages all Qualification activities for newly purchased equipment (Installation, Operational Qualification).
-
Develops and maintains validation master plan, qualification, and validation schedule. Ensures that validation/qualification projects and timelines are structured in accordance with FDA regulatory guidelines. Informs Quality management of validation projects on a regular basis.
-
Resolve difficult technical issues during product and process development using statistical techniques and analysis for continuous improvement of the Quality system.
-
Performs Risk Management activities including FMEAs
-
Recommends and initiates specification and process changes based on statistical analysis of products to ensure the safety, efficacy, and quality of the product.
-
Review, develop, and revise quality related documents as needed.
Requirements:
- Detail oriented with good organizational skills.
- Good communication and interaction skills.
- Able to follow written work instructions.
- Ability to work under minimal supervision.
- Flexibility to work off shift hours.
- Problem Solving and decision making.
- Knowledge of FMEA and risk management
- Must be able to speak, write and read English. Bilingual skills are a plus.
- Minimum 4 years related experience in validations at a manufacturing environment.
- Able to properly use standard inspection equipment (calipers, thickness gage and other, gages etc.).
- Bachelors Degree in related field
- Demonstrated ability to read, understand, and apply the information contained on technical documentation, procedures, drawings, and understand basic geometric tolerances.
- Intermediate computer skills using Word and Excel.
- Must be able to lift and/or move up to 50 lbs.
- Physically capable performing tasks associated with the responsibilities, such as but not limited to:
- Frequent standing, walking, sitting, stoop, kneel, crouch, or crawl; work on an elevated platform or surface; and talk or hear.
- Use hands to finger, handle, or feel objects, tools, or controls; and reach with hands and arms.
Sign up to receive alerts about other jobs with skills like those required for the LC01-120721 - Sr Quality Validation Engineer.
Click the checkbox next to the jobs that you are interested in.
-
Batch Testing Skill
-
Income Estimation: $58,456 - $72,854
-
Income Estimation: $59,353 - $74,358
-
-
Emergency Management Skill
-
Income Estimation: $67,775 - $93,831
-
Income Estimation: $71,842 - $96,462
-
Job openings at Validation & Engineering Group
Simpsonville, SC
Full Time
Windsor, CT
Full Time
Greenville, SC
Full Time
Greenville, NC
Full Time
Not the job you're looking for? Here are some other LC01-120721 - Sr Quality Validation Engineer jobs in the Dallas, TX area that may be a better fit.
We don't have any other LC01-120721 - Sr Quality Validation Engineer jobs in the Dallas, TX area right now.
honeywell2-pilot, Richardson, TX
Rochester Sensors, LLC, Coppell, TX