Associate Validation Engineer

Sterigenics • Grand Prairie, TX, US

12 days ago

Job type

Full-time

Job description

Overview

Associate Validation Engineer at Sterigenics reports to the Quality Assurance (QA) Manager. The role provides leadership and data for all customer validation projects and interfaces with cross-functional teams, customers, and regulatory agencies.

Responsibilities

Plan, organize, and coordinate customer validation activities at the facility.
Write validation protocols and final reports supplied by the facility.
Review and approve customer or consultant supplied protocols for execution within the limitation of the facility's equipment and Sterigenics operating procedures and compliance with current regulatory standards.
Execute validation protocols and technically driven customer projects, including scheduling project runs, ancillary resources, lab testing, sample handling, cycle programming, process documents, safety assessments, microbiological sampling, temperature / humidity probe data collection, and proper handling, storage and shipping of bioburden, LALs, biological indicators, or residual samples.
Assure that all validation calibration activities are performed according to Sterigenics procedures and traceable to NIST.
Provide support to Maintenance or Engineering in the performance of IQ / OQ / PQ activities of new or existing facility equipment and annual equipment re-commissioning (sterilization and laboratory).
Update validation status in the relevant systems and assist with corrective action and validation process improvement activities.

Qualifications

Minimum BA or BS in a science related field (or international equivalent) and / or 4–6 years equivalent experience.

2–4 years of experience in the pharmaceutical, food or medical device industry with GMP / GLP knowledge a plus but not required.

Direct experience in sterility assurance or product sterilization a plus but not required.

Experience in writing and executing validation protocols preferred.

Customer service and project management experience desired.

ISO 9000 experience a plus.

Excellent written and verbal communication skills, strong computer skills, forklift driving experience preferred (internal training provided).

Must be able to lift a minimum of 50 lbs (23 kg) and perform repetitive bending and lifting motions; flexible schedule including weekends, holidays; travel 10–20% to various locations as needed.

Special Requirements

Must possess a thorough understanding of US FDA Quality Systems Regulations, ISO 9000 regulations, and international regulatory requirements.

Knowledge and experience working with the FDA and / or international requirements for medical devices is essential.

Experience in document control to satisfy all ISO 9000 and FDA (or international equivalent) Quality System requirements.

Must be medically approved for respirator use (EO) and able to tolerate exposure to high temperatures and high humidity (up to 130°F and 65% RH for 20 minutes).

Training Required

Must complete all required training for validation internal certification.

Benefits

Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts

401(k) program with Company match that immediately vests

Paid holidays, vacation and sick time

Free financial planning assistance

Paid parental leave

Education assistance

Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance

Employee Assistance Program (EAP)

EEO Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.

VEVRAA Federal Contractor.

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Validation Engineer • Grand Prairie, TX, US