Quality Validation Specialist

THE VISUAL PAK COMPANIES•Waukegan, IL

1d•$87,765 - $131,647

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. Position Purpose/Summary: The Plant Hygienist and Validation Specialist manages, inspects, calibrates, tests, and modifies the instrumentation, equipment, and procedures used to manufacture various products. This role serves as the technical expert for Hygiene programs: Zoning, Pest Control, Cleaning Validation & Verification, Pathogen Monitoring, Foreign Body prevention, and Housekeeping.

Requirements

BS Degree in Microbiology, Science, or equivalent work experience.
Experience in commercial lab settings.
Experience in safety, regulated production/GMP, quality, or other related areas.
Thorough understanding of Good Manufacturing Practices.
Strong organizational, communication, and project management skills.
Exceptional attention to detail.
Proven ability to provide accurate work quality.
Ability to prioritize work assignments.
Ability to work under regular pressure.
Applies critical thinking and sound judgement.
Ability to work in a team environment or independently as required.
Ability to recognize and resolve discrepancies and issues.
5 years of progressive quality-focused experience in a regulated production GMP in contract packaging, blending, and filling light industrial manufacturing, or similar business within a consumer manufacturing environment.
Working knowledge of hygiene practices, regulations, and HACCP principles.
Proven ability to identify hygiene risks.
Ability to adapt to changing regulations.
Knowledge of sanitation equipment, chemicals, and cleaning procedures.
5 years’ experience working in validation services, in a regulated manufacturing environment.
Working knowledge of ISO reqs, CAPA, FMEA, etc.
Knowledge of Validation protocols, IQ-OQ-PQ
Preferred knowledge and experience with Microsoft Dynamics – Navision
Demonstrated Microsoft Office proficiency (Word, Excel, and Outlook)
Able to efficiently create IQ/OQ protocol reports.
Able to create validation protocols.
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.
able to commute to work location.

Responsibilities

Perform regular walkthroughs to ensure manufacturing sites are always audit-ready and in compliance with GMP standards.
Ability to manage multiple and complex projects, provide status reports, and coordinate with other departments and/or outside contractors/vendors to complete assigned tasks.
Provide quality and compliance oversight for scheduled and periodic maintenance activities within the manufacturing facility.
Support customer audits by providing requested documents, as needed.
Oversees environmental and biological monitoring performed by the Microbiology department.
Lead development, implementation, and standardization of internal Microbial Risk Assessments (MRA).
Participate in design review of micro-related projects, especially on equipment, product processes, and utilities (Water system, HVAC, compressed air, and any other direct impact systems).
Monitor and analyze microbiological data for finished goods, bulk, and raw materials.
Monitor manufacturing air and water quality.
Perform microbial risk assessment audits in all production quality-related departments.
Implement corrective actions and suspend operations if required.
Investigate microbial events within the plant to determine a root cause and preventative actions.
Ensure compliance with manufacturing hygiene requirements.
Lead validation compliance projects to meet site qualification and validation requirements.
Provide QA validation and Quality Oversight service to designated manufacturing sites.
Ensure compliance with the validation life cycle.
Review a wide variety of validation documents, including any or all of the following: mechanical, cleaning, automation, calibration, QC methods, and instruments, process systems/equipment, SOPs, Logbooks Validation Maintenance Reports, and Commissioning Documents.
Partner with the Quality Department to ensure documentation/process changes align with regulatory filings and maintain the validated process.
Ensure compliance with the validation life cycle.
SME/training resource to discuss regulatory expectations for validation activities, programs, and documentation.
Create and maintain status updates for qualification/validation activities.
Provide technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in a manufacturing environment.
Validate production lines, water systems, cleaning procedures, existing equipment, and future equipment with internal and customer requirements.
Validate processes and procedures with internal and customer requirements.
Create a validation master schedule.
Ensure requirements for re-validation of equipment are conducted following the equipment’s relocation.
Ensure proper evidence of validation records.
Create validation protocols and process control methods.