Equipment Deviation Investigator Job Listing at Kelly Services in Parsippany Troy Hills, NJ (Job ID US3558594_BH9808096)

Description

Job Type: Full-time- Full benefits, PTO, 401K

Overview: We are seeking an experienced Quality Engineer to join our dynamic Quality & Compliance team at a fast-paced pharmaceutical manufacturing site. In this critical role, you will lead deviation investigations, troubleshoot equipment and process-related issues, and ensure compliance with operational and regulatory standards. Your expertise will help maintain the highest standards of quality and compliance across a variety of systems, including lyophilizers, vial washers, filling lines, HVAC systems, and WFI systems.

Key Responsibilities:

• Lead Deviation Investigations: Own and manage full-cycle deviation investigations from initiation to final resolution and closure, ensuring timely and accurate completion.
• Technical Documentation: Write clear, concise, and technically accurate deviation reports related to engineering, facilities, and equipment—especially for sterile manufacturing equipment such as lyophilizers, vial washers, filling lines, and HVAC systems.
• Cross-functional Collaboration: Troubleshoot and work closely with cross-functional teams, including QC, Microbiology, Supply Chain, Facilities, and Engineering, to identify root causes and develop corrective actions.
• Regulatory Compliance: Ensure all activities and documentation adhere to cGMP, FDA regulations, and internal SOPs.
• Deviation Management: Manage deviation records through TrackWise and Oracle EAM systems, with future transitions to SAP.
• Preventive Actions: Contribute to the reduction of overdue deviations, focusing on recurring facility-related issues like humidity control, and provide insights to prevent future deviations.
• Operational Support: Provide technical guidance on sterile filling, WFI systems, and environmental systems, ensuring all systems are compliant with industry standards.

Qualifications:

• Experience: 3+ years of engineering or compliance experience in a GMP-regulated facility (preferably in sterile or aseptic manufacturing environments).
• Education: Degree in biology, engineering, or a related field.
• Deviation Investigation: Proven experience in leading and completing deviation investigations with full ownership and accountability.
• Technical Knowledge: Strong technical understanding of pharmaceutical manufacturing equipment and systems, including lyophilizers, filling lines, and HVAC.
• Systems Knowledge: Familiarity with systems such as TrackWise, Oracle EAM, and/or SAP.
• Collaborative Skills: Ability to thrive in a fast-paced, cross-functional, and collaborative work environment.
• Strong Writing Skills: Ability to author detailed and accurate investigation reports, including root cause analysis (e.g., 6Ms, 5 Whys) and CAPAs.
• Preferred Experience: Previous experience with fill/finish environments and associated equipment is a plus.

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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