Description We are seeking a highly motivated and detail-oriented Validation/Quality Engineer to support our manufacturing operations. This role is critical in ensuring compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. The ideal candidate will lead validation activities, maintain robust quality systems, and drive continuous improvement initiatives across manufacturing processes. Key Responsibilities: Validation & Qualification: Develop and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and systems. Lead risk assessments and validation strategy development in alignment with regulatory requirements. Maintain validation master plans and ensure timely revalidation. Quality Systems & Compliance: Support and maintain quality systems including CAPA, nonconformance, change control, and document control. Ensure compliance with FDA, ISO, and internal quality standards. Participate in internal and external audits, including FDA inspections. Documentation & Reporting: Prepare and review technical documentation including validation reports, SOPs, and work instructions. Ensure accurate and timely documentation in accordance with Good Documentation Practices (GDP). Cross-Functional Collaboration: Work closely with manufacturing, engineering, regulatory, and quality assurance teams. Provide training and guidance on validation and quality system requirements. Continuous Improvement: Identify and implement process improvements to enhance product quality and operational efficiency. Utilize tools such as Six Sigma, Root Cause Analysis, and FMEA. Qualifications: + MUST come from a Life Sciences Manufacturing (GMP) background + 5-10 years of Validation related experience. Pay and Benefits The pay range for this position is $60.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Scarborough,ME. Application Deadline This position is anticipated to close on Jul 9, 2025. h4>About TEKsystems: We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. About TEKsystems and TEKsystems Global Services We’re a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We’re a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We’re strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We’re building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.