Validation Engineer

• II Nurse Assist, Inc.
• 3.

6 Haltom City, TX Job Details Full-time 20 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Retirement plan Qualifications Certified Manufacturing Engineer (CMfgE) Certified Quality Technician Production validation processes Medical device manufacturing facility experience Pharmaceutical company experience Vendor communication Collaboration with manufacturing teams Certified Manufacturing Technologist (CMfgT) CPIM Productivity software Certified Quality Engineer Pharmaceutical manufacturing facility experience Full Job Description

JOB TITLE

Validation Engineer

II DEPARTMENT

Quality

POSITION REPORTS TO

Vice President of Quality

SALARIED

[ X ]

BASIC PURPOSE OF POSITION

Develop and evaluate manufacturing processes and systems and perform validation testing to ensure compliance with standards and regulations. Technical quality assurance resource for all Operations and QA areas. Analyzes existing operations against the requirements of ISO 13485 and 21

CFR:

820 and proposes enhancements in compliance with those operations, to those regulations. Provides guidance on solutions to moderately complex problems.

ESSENTIAL FUNCTIONS/DUTIES

Coordinating and directing validation activities. Measuring production processes and parameters against internal and industry standards. Drafting technical protocols and reports to support validation activities. Establishing validation standards and developing performance testing and quality control measures. Analyzing test data. Presenting validation test results and recommending improvements. Maintaining master validation planning records. Provide technical expertise for new product development and sustaining production. Support development and implementation of risk management activities such as Hazard Analysis and

FMEA. KEY WORKING RELATIONSHIPS

INTERNAL:

Must be able to work as part of an interdisciplinary team, interacting easily with the members of the team. Must be able to support the ongoing manufacturing of products. Must be able to provide technical consultation to other personnel in a positive, supportive way.

EXTERNAL

Must be able to work with outside vendors in support of product production and testing. Must be able to interact with customers in solving customer problems. Must be able to work with external auditors.

SUPERVISORY RESPONSIBILITIES

None

EDUCATION AND EXPERIENCE REQUIREMENTS

Bachelor's or Master's Degree in Engineering, Microbiology, Chemistry or related field Must have 2-3 year of validation experience in medical device or pharmaceutical production/manufacturing environment. Must be proficient in the use of office automation software including MS Word and Excel.

PREFERRED QUALIFICATIONS

Experience with

ISO 13485

regulations and FDA GMP and QSR Multilingual (English and Spanish are a plus)

JOB REQUIREMENT FACTOR RATINGS

H

• High importance M
• Medium importance L
• Low importance Hearing H Seeing H Reading H Speaking H Balancing M Walking M Use of hands H Use of arms H Use of legs M Lifting (max of 20 lbs.

)

M Bending M Standing L Sitting H Benefits:

401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Retirement plan Vision insurance

Work Location:

In person