Job Title: Validation Engineer Job Description The overall goal of the Validation Engineer is to ensure that all manufacturing processes (internal and outsourced) used by the company to manufacture medical devices are validated to ensure product quality and compliance with federal regulations and industry standards, including but not limited to 21 CFR 820 and ISO standards. MUST HAVE MEDICAL DEVICE EXPERIENCE. Responsibilities + Ensure that facilities, processes, and equipment used in the support of the Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements. + Coordinate validation activities with other sites, departments, and subcontractors. + Maintain the validation master plan to ensure that routine re-validations and project-related validations are completed on time. + Analyze data, procedures, and requirements with consideration given to company goals. + Apply basic risk management principles to all activities and tasks. + Identify areas for process improvement and provide supporting information for change, including reasons and justifications. + Participate in the development or modification of validation packages and deliverables, including risk assessments, plans, requirements, and protocols. + Work directly with suppliers to ensure validations are performed correctly and documented completely. + Work independently with objectives given by the Project Manager. + Plan and coordinate own work according to higher-level project schedules. + Review documentation for accuracy, clarity, consistency, completeness, and compliance for multiple projects. + Report unexpected events, issues, or delays to the project team and management. + Maintain schedule and drive to meet validation schedule as aligned with project goals. + Other assigned responsibilities upon request. Essential Skills + Validation protocols + OQ, IQ, GMP, Process validation + Validation testing + Medical device validation + Equipment validation + Engineering + Quality assurance + Method validation + FDA regulations + Equipment qualification + Ability to create protocols from scratch + Experience creating master plans for new protocols + Capability studies Additional Skills & Qualifications + Bachelor’s degree in engineering or equivalent work experience. + Knowledge of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11/Annex 11. + Project experience in validation testing practices, methodologies, and techniques, particularly in testing medical devices or experience leading a test engineer team. + Ability to work independently and in a team environment. + Knowledge of company products and the orthopedic shoulder industry. + Strong analytical and problem-solving skills. + Demonstrated accuracy and attention to detail. + Excellent oral and written communication skills. + Proficiency with MS Office products, specifically Word and Excel. Work Environment The role involves validation of machinery, machine parts, coating, instruments, laser etching, packaging, labeling, molding, sterilization (ETO or Gamma), and implants on the manufacturing floor. The engineer will be the sole Validation Engineer in the US and will work with outside vendors, which will expand from one to four by the end of the year, including areas like packaging, labeling, sterilization, coating, etc. The position requires the creation of protocols from scratch and managing the master plan for these protocols. Pay and Benefits The pay range for this position is $38.00 - $43.00 About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.