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IG Commissioning & Qualification Lead
Posted: 05/22/2025
2025-05-22
2025-07-24
Employment Type:
Temp
Category: Life Sciences
Job Number: 261588
Pay Rate: 55.00 to 85.00 an hour
Job Description
IG C&Q Stream Lead:
Kanakee, IL
Project will be 2 weeks onsite in Kankakee, IL then 2 weeks remote. Starting in 2026 they will be fully onsite until the end of 2028. This is a long-term engagement. ( 3+Years)
We are seeking an experienced IG Process Stream Leader to oversee a critical fill and finish expansion at our brownfield manufacturing site in the Chicago suburbs. In this pivotal role, you will lead the commissioning and qualification of sophisticated pharmaceutical processing systems including powder distribution areas, buffer tanks, filtration systems, chromatography skids, and CIP equipment. This expansion project requires seamless integration of new equipment into existing infrastructure while ensuring compliance with FDA 21 CFR Part 211, EU Annex 1, and ICH Q10 guidelines.
As the Stream Leader, you will apply your expertise in pharmaceutical manufacturing C&Q to navigate the unique challenges of brownfield expansion, including legacy system constraints and contamination risk mitigation. Additionally, you will help implement Industry 4.0 technologies to modernize operations and enhance manufacturing capabilities.
Location and Work Schedule
Location: Chicago Suburbs, Illinois
Work Model: Initial hybrid arrangement (2 weeks on-site, 2 weeks remote) transitioning to full on-site presence from January 2026.
Location: Chicago Suburbs, Illinois
Work Model: Initial hybrid arrangement (2 weeks on-site, 2 weeks remote) transitioning to full on-site presence from January 2026.
Job Requirements
Key Responsibilities
-Lead detailed design and Design Qualification (DQ) activities for all systems in scope, ensuring proper integration with automation systems
-Lead detailed design and Design Qualification (DQ) activities for all systems in scope, ensuring proper integration with automation systems
-Develop comprehensive commissioning test plans with SMART acceptance criteria (Sensible, Maintainable, Accurate, Range, Traceable)
-Create and review commissioning documentation hierarchies, including overall commissioning plans and system-specific test scripts
Equipment Commissioning & Qualification
-Direct C&Q activities for specialized pharmaceutical processing equipment according to cGMP requirements
-Direct C&Q activities for specialized pharmaceutical processing equipment according to cGMP requirements
-Apply integrated commissioning and qualification approaches to streamline validation efforts while maintaining regulatory compliance
-Coordinate Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities with vendors and internal teams
-Challenge installed systems to verify they meet acceptance criteria, alarms, safeties, and automatic operations
System Implementation & Oversight
-Oversee operation, troubleshooting, and qualification of specialized equipment including:
-Oversee operation, troubleshooting, and qualification of specialized equipment including:
-Powder distribution area and suspension tanks
-Multiple buffer tanks and filtration systems
-Filterpress and filtration tanks
-Ultrafiltration and chromatography skids
-Nanofiltration pre-filters and virus filtration skids
-CIP skids and associated systems
Compliance & Quality Management
-Ensure all equipment is operated, maintained, and qualified according to established procedures and cGMP requirements
-Ensure all equipment is operated, maintained, and qualified according to established procedures and cGMP requirements
-Maintain rigorous compliance with FDA 21 CFR Part 211, EU Annex 1, ICH Q10 guidelines, and company policies
-Oversee quality control and comprehensive reporting of all defects and process deviations
-Ensure proper documentation of all commissioning and qualification activities to meet regulatory standards
-Participate in regulatory inspections as subject matter expert for fill and finish expansion
Required Qualifications
-Bachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field
-Bachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field
-Minimum 8+ years of experience in pharmaceutical C&Q, with previous experience in fill and finish brownfield expansion
-Demonstrated experience with commissioning and qualification of pharmaceutical manufacturing equipment
-Proven experience with specialized equipment including CIP/SIP systems, bulk feed lines, product transfer lines, sterile bulk feed vessels, filtration systems, and chromatography equipment
-Strong understanding of cGMP regulations, particularly FDA 21 CFR Part 211 and EU Annex 1 requirements
-Expertise in mitigating contamination risks and navigating legacy system constraints in brownfield expansions
Leadership Skills
-Strong people management and team leadership abilities with experience directing cross-functional teams
-Strong people management and team leadership abilities with experience directing cross-functional teams
-Excellent project management skills, including scheduling and resource allocation for complex pharmaceutical projects
-Effective communication skills to interface with stakeholders across engineering, quality, manufacturing, and regulatory affairs
-Demonstrated ability to lead in high-pressure environments and manage multiple competing priorities
-Technical problem-solving skills with focus on practical, compliant solutions
Preferred Qualifications
-Master's degree in Engineering, Pharmaceutical Sciences, or related field
-Master's degree in Engineering, Pharmaceutical Sciences, or related field
-Experience with new facility startups or major capital projects in pharmaceutical manufacturing
-Understanding of Industry 4.0 concepts and implementation in pharmaceutical manufacturing
-Six Sigma certification or other quality improvement methodologies
-Experience with risk-based approaches to commissioning and qualification of pharmaceutical systems
-Knowledge of current industry best practices for aseptic processing and contamination control
Meet Your Recruiter
Erin Hoke
My career began in the hospitality industry, but I sought a change for better work-life balance and family considerations. I moved into the world of recruiting in 1999, I started in light industrial roles and gradually specialized in contract and permanent placements across a wide range of technical industries.
In 2006, I co-founded Recruiting Resources with my father, focusing on professional services and human resources staffing for both small and national companies. In 2011, I became an independent recruiter, partnering with a small Firm in the Maryland area where I concentrated on sourcing talent primarily for the Life Sciences industry but also expanded into non-technical areas.
Throughout my career, I have valued personal connections and helping individuals find positions that align with their expertise and lifestyle. My journey reflects adaptability, entrepreneurship, and a passion for facilitating meaningful career opportunities for others. I joined Lloyd Staffing in Aug 2024 to specialize again in Life Sciences.
In my free time, I spend most of my time with my son. We have become quite the fishermen over the past 5 years.