Quality Validation Specialist

THE VISUAL PAK COMPANIES•Waukegan, IL

About The Position

The Visual Pak Companies are aligned with many of the largest consumer product companies in the household, personal care, automotive and food product industries. 30 years of consistent growth with no end in sight is a testament to our best-in-class workforce as the foundation for our collective success. The Visual Pak is looking for innovative and dedicated achievers who are encouraged to keep a healthy work/life balance to join our team. The Validation Specialist is responsible for leading and executing validation activities that ensure manufacturing processes, equipment, utilities, cleaning procedures, and control systems comply with internal standards, customer requirements, and applicable regulatory guidelines. This role serves as a key Quality Oversight and Subject Matter Expert (SME) for validation lifecycle management within a contract manufacturing facility.

Requirements

Bachelor’s degree in engineering, Life Sciences, or related field.
1–3+ years of validation experience in pharmaceutical, cosmetic, medical device, or contract manufacturing environments.
Strong knowledge of validation lifecycle principles, including IQ/OQ/PQ, equipment qualification, process, cleaning, utility, and method validation.
Working knowledge of cGMPs, ISO requirements, CAPA, FMEA, and applicable regulatory expectations.
Excellent technical writing and documentation skills, with experience authoring and executing validation protocols and reports.
Strong analytical, critical-thinking, and problem-solving skills, with the ability to identify, investigate, and resolve discrepancies.
Effective project management skills, including the ability to prioritize tasks and manage multiple assignments in a fast-paced environment.
Ability to work independently while collaborating effectively with cross-functional teams and external clients.
Demonstrated ability to work under pressure while maintaining attention to detail and compliance.
Must have strong written and verbal communication skills.
Ability to communicate effectively with various levels of personnel.
Demonstrated talent for understanding the audience and how to communicate the message effectively.
Ability to lift up to 40 pounds.
Ability to stand or sit for long periods.
Reasonable capacity so as to accept work direction or training in a loud, busy environment.
Reasonable capacity to perform job duties and understand work resources and work environment.

Nice To Haves

Preferred knowledge and experience with Microsoft Dynamics – Navision
Demonstrated Microsoft Office proficiency (Word, Excel, and Outlook)

Responsibilities

Support customer audits and inspections by serving as the Validation Subject Matter Expert (SME) and providing requested documentation.
Lead and manage validation compliance projects to meet site qualification, validation, and regulatory requirements.
Provide QA validation oversight and quality support to assigned manufacturing sites.
Ensure validation activities comply with the full validation lifecycle and applicable regulatory expectations.
Review, approve, and maintain validation-related documentation, including protocols, reports, SOPs, logbooks, commissioning documents, calibration records, automation, cleaning, QC methods, instruments, and equipment/system qualifications.
Partner with Quality and cross-functional teams to ensure process and documentation changes align with regulatory filings and maintain the validated process.
Act as a technical SME and training resource for validation programs, activities, documentation, and regulatory expectations.
Develop, execute, and maintain validation protocols, reports, and process control strategies.
Create and maintain status updates for qualification/validation activities.
Create a validation master schedule and maintain a validation matrix.
Provide technical validation engineering support for equipment and process upgrades, replacements, modifications, and relocations.
Execute and oversee validation of production lines, utilities (including water systems), cleaning procedures, and new or existing equipment in accordance with internal and customer requirements.
Ensure re-validation activities are appropriately conducted following equipment relocation or significant change.
Ensure validation records are complete, accurate, and properly maintained as objective evidence of compliance.
Create validation protocols, reports and process control methods.
Contributes to department success by ensuring validation compliance with internal and external requirements.
Validation records are maintained and created with accuracy and appropriate timeliness.
Validations requirements are completed on-time.