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Validation Engineer Manager Nurse Assist, Inc.

• 3.6 Haltom City, TX Job Details Full-time $25.98
• $31.

29 an hour 19 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Management ISO standards GMP Project management experience in manufacturing MRP Manufacturing facility experience Supervising experience Managing engineering teams Production validation processes Medical device manufacturing facility experience Sterile processing regulatory compliance Production management systems Microsoft Teams Technical writing Regulatory/legal compliance standards in production Biomedical regulatory compliance Productivity software Managing product quality assurance teams Project stakeholder communication Cross-functional communication FDA regulations Pharmaceutical manufacturing facility experience Full Job Description

JOB DESCRIPTION JOB TITLE

Validation Engineer Manager Department:

Quality Position Reports To:

Vice President of Quality Salaried:

[ X ]

Basic Purpose of Position:

This position reports to the Vice President of Quality and owns the strategic execution, maintenance, and compliance of the Validation Master Plan (VMP) at Nurse Assist. The role oversees the qualification and validation systems to ensure all equipment, processes, utilities, software, and sterilization methods comply with ISO 13485 and 21 CFR Part 820 regulations. Serves as the primary technical quality assurance resource for validation strategies, drives continuous improvement in accordance with the company's quality policy, and partners with engineering and manufacturing leadership to ensure production processes remain in a continuous state of compliance and control. Essential Functions /

Duties:

Validation Master Plan Ownership:

Manages, maintains, and executes the company's Validation Master Plan (VMP) covering equipment, processes, software, utilities, test methods, and sterilization.

Protocol & Report Approval:

Reviews and formally approves technical validation protocols and final reports (including IQ, OQ, PQ, and PV) drafted by engineering teams to ensure compliance and technical integrity.

Sterilization & Packaging Compliance:

Provides technical quality oversight and approval for sterilization validation (Gamma and EtO) and medical device packaging validation activities in accordance with current ISO standards.

Quality Metrics & Reporting:

Prepares, tracks, and reports validation key quality indicators and metric trends to executive management, identifying necessary inputs into the continuous improvement process.

Risk Management Integration:

Leads, reviews, and approves risk management activities, including Hazard Analysis, Process FMEAs (pFMEA), and risk-based validation rationales.

Audit Support & SME Representation:

Acts as the primary Subject Matter Expert (SME) during internal, vendor, customer, and regulatory audits (FDA, ISO) for all validation and sterilization files.

Deviation & CAPA Management:

Oversees and manages technical investigations related to validation deviations, nonconforming materials, and corrective/preventive actions (CAPA) stemming from process or equipment failures.

Supplier & Vendor Assessment:

Provides technical validation support for external suppliers, contract manufacturers, and testing laboratories through technical evaluations, audits, and protocol alignment.

Process Improvement:

Evaluates, updates, and optimizes validation procedures, corporate policies, and quality standards to drive technical efficiency and maintain strict regulatory compliance.

Production Support:

Partners with operations and engineering teams to provide root-cause analysis and problem resolution for moderately complex production, validation, or equipment issues.

Key Working Relationships:

Internal:

Works collaboratively across interdisciplinary teams, interacting closely with Quality Assurance, Manufacturing Engineering, and Operations. Communicates validation status, project risks, and technical compliance strategies directly to senior management and executive leadership.

External:

Collaborates with outside vendors, test laboratories, and contract packagers/sterilizers to support product testing and production. Directly interfaces with customer technical contacts and external regulatory auditors during inspections.

Supervisory Responsibilities:

Responsible for the oversight of validation projects and cross-functional project teams. (

Optional:

Direct management of Validation Engineers/Specialists as assigned).

Education and Experience Requirements:

Bachelor's or Master's Degree in Engineering, Microbiology, Chemistry, or a related technical field (or equivalent experience). Deep working knowledge of

ISO 13485

regulations, FDA GMP, and QSR (21 CFR Part 820). Minimum 6 years of experience in an FDA/GMP facility within the medical device or pharmaceutical manufacturing industry. Minimum of 4 years of direct experience in a QA/QC function, with demonstrated experience leading validation projects or technical teams. Direct experience with Sterilization (Gamma and EtO) and medical device packaging ISO standards and requirements. Excellent verbal and written skills for communicating technical requirements internally and externally (to customers, vendors, and regulatory bodies). Proficient in the use of office automation software including MS Word, Excel, MS Teams, and ERP/MRP systems.

Preferred Qualifications:

Multilingual capabilities (English and Spanish are a plus). Experience with Computer System Validation (CSV) regulations and automated manufacturing software standards.

Job Requirement Factor Ratings:

(H

• High Importance | M
• Medium Importance | L
• Low Importance)

Hearing:

H Seeing:

H Reading:

H Speaking:

H Balancing:

M Walking:

H Use of hands: H Use of arms: H Use of legs: M Lifting (max of 20 lbs.):

M Bending:

M Standing:

M Sitting:

M Pay:

$25.98

• $31.

29 per hour

Benefits:

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

Work Location:

In person