Validation Engineer IV - The Fountain Group

Abbott Park, IL

About the Job

Hello,

My name is Ram, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Validation Engineer/FUE Engineer for a prominent client of ours. This position is located North Chicago, IL. Details for the position are as follows:

Job Title: Validation Engineer/FUE Engineer
Location: North Chicago, IL
Duration: 2 year contract

Travel: 25% – 50% travel – will not be at a site longer than a month (open to travel home on the weekends) – all travel is domestic travel

Required:

Must have Facilities, Utilities, Equipment Validation experience. (GMP Prefers)
Open to domestic travel

Job Description:
Looking for an outstanding Principal Validation Engineer who will effectively lead quality related validation activities to support the Quality Management System. The end goal is to deliver high-quality validation and supporting documentation. This role requires strong technical, communication, interpersonal and organizational skills, and a solid understanding of the application of Regulatory, ISO standards and company policies, processes, procedures and guidelines. The successful candidate will be able to perform, plan, schedule and estimate discipline project costs including writing, updating and reviewing of engineering studies, user requirements, validation plans, qualification protocols and reports. Generate, input, route and review items for approval in the quality system.

Education/Experience Requirements

Bachelors’ degree (B.S.) in a Science related field (Engineering, Biology, Chemistry, other technical degree OR relevant combination of education or experience)

5-10 years of related work experience in a medical device or other healthcare industry with strong technical competency in performing facility/utilities/equipment qualification, et al. validations
Must be familiar with good documentation practices (GDP) and cGMP environment
Strong validation experience in the following areas: Facilities (Clean rooms, HVAC/ Environmental Monitoring Program), Utilities (Water Systems), Equipment (Washers, Autoclaves and Fillers), Automated Process Controls, Statistical Sampling and Process Monitoring (SPC)
Has a history of completing successful cross-functional projects and driving positive, compliance outcomes
Proficient using Microsoft Word, Excel and Outlook for reporting and email correspondence.

Preferred

Experience in temperature/humidity mapping studies and validation of facilities storage spaces and manufacturing rooms, as well as environmental equipment (e.g., Freezers, Refrigerators, Humidity Chambers, Incubators, etc.)
Experience with troubleshooting and commissioning of commercial and/or industrial refrigeration systems, HVAC units, utilities distribution and controls (multiple platforms is a plus)

Responsibilities

Maintaining the integrity of the Client’s Quality System
Act as a single point-of-contact to interface with Client’s division customers
Develop and manage documentation for engineering studies (“ES”). Execute ES activities.
Develop and manage documentation for commissioning tests (“CT”). Execute CT activities as required
Develop and maintain the validation traceability matrix (“VTM”)
Provide data entry and statistical analysis of data collected during validation activities
Develop documentation for GMP criticality assessment and coordinate activities
Interprets validation/user requirements, provides validation strategy in conjunction with division quality and operations organizations, develops and drafts validation protocols [i.e. Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification (DQ/IQ/OQ/PQ),] executes validations and documents validation results in final reports
Ensures that validations are documented using Good Documentation Practices and in compliance with Medical and Nutritional Agency Regulations, ISO Standards, and Policies and Procedures
Perform and document investigations related to validation activities and performs risk assessments of equipment and processes to support scope of validation
Identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance
Provide quality-related discipline expertise to divisional customers, project teams and consultation to direct and contingent project personnel
Performs other duties as assigned by Management.

Other Requirements

Must be able to travel for extended periods averaging 1-2 weeks per month as required; Approximately 25% to 50% of the work may require domestic and/or international travel
Candidate must be capable of working independently and/ or on project teams, adapting to a flexible work schedule, paying attention to detail, performing critical analysis of situations and providing recommendations.

Source : The Fountain Group