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-Lead detailed design and Design Qualification (DQ) for all systems within scope, ensuring proper integration with automation systems
Manufacturing Engineer
Posted: 05/22/2025
2025-05-22
2025-07-24
Employment Type:
Temp
Category: Life Sciences
Job Number: 261587
Pay Rate: 55.00 to 85.00 an hour
Job Description
Fractionation - C&Q Stream Leader:
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)
The Fractionation Stream Leader will spearhead the commissioning and qualification (C&Q) activities for a comprehensive portfolio of specialized systems including Water Bath, Plasma Bottle Cutting Robot, Plasma Bottle Shredder, Thawing Tank, Centrifuge, Buffer Tanks, Solid Handling Area, Post/Pre Wash Areas, Precipitate Tanks, Filter Presses, CIP Skids, and Parts Washers. This position is critical to our brownfield expansion project, requiring expertise in integrating new equipment while maintaining ongoing operations in accordance with FDA 21 CFR Part 211, EU Annex 1, and ICH Q10 regulatory frameworks.
-Lead detailed design and Design Qualification (DQ) for all systems within scope, ensuring proper integration with automation systems
-Develop comprehensive commissioning and qualification strategies aligned with project timelines and regulatory requirements
-Apply risk-based approaches to C&Q planning to optimize resource utilization while maintaining compliance
Commissioning and Qualification Leadership
-Direct all C&Q activities according to cGMP requirements, applying integrated approaches to streamline validation efforts
-Direct all C&Q activities according to cGMP requirements, applying integrated approaches to streamline validation efforts
-Develop and execute commissioning test plans with SMART acceptance criteria (Sensible, Maintainable, Accurate, Range, Traceable)
-Challenge installed systems to verify proper functioning, including alarms, safeties, and automatic operations
-Lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities for critical equipment
Documentation and Compliance Management
-Create and review comprehensive commissioning documentation hierarchies, including master plans, test scripts, and system-specific protocols
-Create and review comprehensive commissioning documentation hierarchies, including master plans, test scripts, and system-specific protocols
-Ensure proper documentation of all C&Q activities in accordance with regulatory standards and company procedures
-Maintain strict compliance with cGMP, safety regulations, ISO requirements, and company policies
-Oversee quality control reporting for all defects, process deviations, and product deviations
Equipment Oversight
-Coordinate commissioning, qualification, and validation of specialized fractionation equipment including CIP skids, SIP systems, bulk feed lines, and product transfer lines
-Coordinate commissioning, qualification, and validation of specialized fractionation equipment including CIP skids, SIP systems, bulk feed lines, and product transfer lines
-Ensure proper operation, maintenance, and qualification of sterile bulk feed vessels, inspection machines, autoclaves, and depyrogenation tunnels
-Oversee installation and qualification of critical components including isolators, filler/stoppering systems, and capping machines
Regulatory and Project Leadership
-Serve as subject matter expert during regulatory inspections related to the fill and finish expansion
-Serve as subject matter expert during regulatory inspections related to the fill and finish expansion
-Apply Pharma 4.0™ principles to modernize operations through digitalization and automation technologies
-Coordinate with cross-functional teams including Engineering, Operations, Quality, and external vendors
Job Requirements
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 expertise with commissioning and qualification of pharmaceutical manufacturing equipment
-Proven experience with fractionation systems and equipment including centrifuges, CIP skids, filter presses, and plasma processing equipment
-Comprehensive knowledge of cGMP regulations, FDA 21 CFR Part 211, EU Annex 1, and ICH Q10 guidelines
-Experience developing and executing commissioning test plans, protocols, and qualification documentation
Leadership Skills
-Demonstrated ability to manage and lead validation teams through complex projects
-Demonstrated ability to manage and lead validation teams through complex projects
-Strong project management capabilities, including scheduling, resource allocation, and timeline management
-Excellent communication skills for effective collaboration with cross-functional teams and stakeholders
-Proven capacity to lead in high-pressure environments while managing multiple priorities
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 environments
-Understanding of Industry 4.0 concepts and implementation in pharmaceutical manufacturing
-Six Sigma certification or other quality improvement methodologies
-Experience implementing risk-based approaches to commissioning and qualification activities
-Knowledge of ISPE Baseline Guide Vol 5: Commissioning and Qualification practices
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.