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Validation Engineer
Job Description
- Support and implement new laboratory systems, testing, management, troubleshooting, and administration of new and existing systems within a Pharmaceutical lab environment which include but not limited to Chromatography Data Systems such as Empower, UV-Vis, GCMS, FTIR, LIMS, Mastersizer and other standalone equipment.
- Support the development, revision, and review of written procedures for system administration of GxP systems in both Laboratory and manufacturing areas.
- The candidate must have the ability to independently perform evaluation of applications, instruments and equipment for 21 CFR Part 11 compliance and to create a gap analysis, suggest and implement corrective actions.
- The candidate must be able to author compliant (Administration and Usage) SOPs and other documents as per the company’s standards and processes.
- Strong computer, scientific, and organizational skills
- Proficient in MS Project and other planning / scheduling tools.
- Knowledge of 21 CFR Part 11 and data integrity requirements
- Knowledge of risk-based Change Management and Quality Management systems like EDMS & TrackWise preferred.
- Laboratory systems usage experience. Understanding of what the above systems perform (analysis), how they are configured and connected to instruments and servers.
- Strong understanding of Data Integrity principles.
- Strong in:
- Computer System Validation
- Equipment Qualification
- Spreadsheet Validation
- Facility Validation
- Utility Validation
- Validation Lifecycle management
- Risk Management lifecycle understanding
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.