Validation Engineer II - Smoke Studies

Advantage Technical; Woodstock (IL); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Advantage Technical seeks an experienced Validation Engineer II to support qualification and validation activities in a sterile pharmaceutical manufacturing environment. You will plan, execute, and document smoke studies in Grade A–D cleanrooms and develop robust validation protocols with clear acceptance criteria.

The role involves coordinating with Engineering, Manufacturing, QA/QC, Regulatory Affairs, and other teams.

Qualifikationen

• Bachelor’s degree in engineering or related technical discipline.
• 3+ years of validation experience with a bachelor’s degree (2+ years for Master’s).
• Smoke studies in Grade A–D cleanrooms.
• Strong knowledge of FDA/CGMP guidance for aseptic environments.
• Experience in sterile pharmaceutical/biologics environments.
• Knowledge of cGMP and validation principles.
• Experience developing validation protocols and final reports.

Aufgaben

• Plan, coordinate, execute, and document smoke studies in Grade A-D areas.
• Develop validation protocols with clear specifications and acceptance criteria.
• Evaluate study results and document observations, deviations, and conclusions.
• Support qualification of facilities, cleanrooms, equipment, utilities, processes, and controls.
• Act as validation representative on cross-functional project teams and lead when assigned.
• Research regulatory requirements for assigned validation activities.
• Schedule validation execution with Manufacturing, Engineering, QA, QC, and Regulatory Affairs.
• Prepare validation reports and documents summarizing results and compliance.
• Develop complex validation procedures and test methods with high accuracy.
• Prepare test plans for equipment changes and project activities.
• Provide validation support to Engineering, Manufacturing, QA, QC, and Regulatory Affairs.
• Assist in developing and revising validation SOPs and quality standards.
• Support inspections by internal, customer, and regulatory bodies.
• Collaborate with management and stakeholders to identify and manage risks.

Kenntnisse

Smoke studies

FDA requirements

Sterile environment

Validation principles

Independent work

Project management

Technical writing

Cross-functional work

Ausbildung

Bachelor’s degree in Engineering/Life Sciences/Physical Sciences

Master’s degree (optional)

Tools

Microsoft Office

Jobbeschreibung

Contract Duration: Through at least April 2027

Schedule: Primarily day shift; flexibility required based on validation activities

Hours: Must be available to work extended schedules as needed, up to approximately 50 hours per week

Position Overview

We are seeking an experienced Validation Engineer II to support qualification and validation activities within a sterile pharmaceutical manufacturing environment. A key focus of this assignment will be the planning, execution, documentation, and evaluation of smoke studies within Grade A-B-C-D cleanroom environments.

The Validation Engineer II will design, schedule, execute, and evaluate scientifically sound validation studies to demonstrate that critical equipment, facilities, utilities, processes, cleaning systems, and controls operate consistently and in compliance with cGMP and applicable regulatory requirements.

This individual will work closely with Engineering, Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, and other cross-functional teams. The ideal candidate is meticulous, results-oriented, self-motivated, and capable of independently driving validation activities in a fast-paced environment.

Key Responsibilities

• Plan, coordinate, execute, and document smoke studies / airflow visualization studies within Grade A-B-C-D classified areas.
• Develop and execute validation protocols with clearly defined specifications, acceptance criteria, and assessment methods.
• Evaluate smoke-study results and document observations, deviations, conclusions, and recommendations.
• Support qualification of facilities, cleanrooms, equipment, utilities, processes, controls, and cleaning systems.
• Serve as a validation representative on cross-functional project teams and, when assigned, provide project-level validation leadership.
• Research and interpret applicable regulatory and cGMP requirements for assigned validation activities.
• Schedule and coordinate validation execution with Manufacturing, Engineering, Quality, and other supporting departments.
• Prepare detailed validation reports and documentation summarizing study results and compliance with acceptance criteria.
• Develop and execute complex validation procedures and test methods with a high level of accuracy and quality.
• Prepare test plans associated with equipment changes and other project activities.
• Provide technical validation support to Engineering, Manufacturing, QA, QC, Regulatory Affairs, and other departments.
• Assist with development and revision of validation SOPs, policies, programs, and quality standards.
• Support internal, customer, and regulatory inspections.
• Work directly with management, contract customers, engineers, and other technical stakeholders.
• Identify, evaluate, and manage risks that could affect product quality or validation outcomes.
• Maintain complete and accurate validation documentation in accordance with applicable Quality System requirements.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Physical Sciences, or a related technical discipline preferred.
• Approximately 3+ years of directly related validation experience with a bachelor’s degree, or an equivalent combination of education and experience.
• Master’s degree with approximately 2+ years of related experience may also be considered.
• Hands-on experience performing smoke studies / airflow visualization studies in Grade A, B, C, and D cleanroom environments.
• Strong working knowledge of FDA requirements, expectations, and guidance related to smoke studies / airflow visualization in aseptic processing environments.
• Experience working within a sterile pharmaceutical, biologics, aseptic manufacturing, or similarly regulated environment.
• Working knowledge of cGMP, validation principles, pharmaceutical manufacturing practices, and Quality Systems.
• Experience developing and executing validation protocols and preparing final reports.

Knowledge & Skills

• Strong understanding of cleanroom validation and smoke-study execution.
• Meticulous attention to detail and commitment to accurate documentation.
• Strong analytical, investigative, and problem-solving skills.
• Self-motivated and capable of working independently with limited supervision.
• Results-oriented with the ability to manage multiple projects and meet aggressive timelines.
• Strong technical writing and documentation skills.
• Ability to interpret technical instructions, diagrams, specifications, protocols, and schedules.
• Strong interpersonal and communication skills with the ability to work across Manufacturing, Engineering, and Quality organizations.
• Proficiency with Microsoft Office and related business applications.
• Strong mechanical aptitude and understanding of safe work practices.

Schedule & Assignment Requirements

• Must be available to work up to approximately 50 hours per week when project demands require.
• Work will be primarily day shift, although hours may vary depending on production and validation schedules.
• Must be flexible to support smoke studies and validation activities outside normal business hours when required.
• Contract assignment is expected to continue through at least April 2027.

Physical Requirements & Work Environment

• Frequent sitting, standing, walking, reading technical documentation, computer use, reaching, writing, speaking, and listening.
• Occasional bending, grasping, carrying, stooping, kneeling, and crouching.
• Frequent lifting or moving of items up to 10 pounds and occasional lifting up to 30 pounds.
• Work will take place in a fast-paced sterile manufacturing and cleanroom environment requiring adherence to gowning, safety, and contamination-control procedures.