Senior Validation Engineer

About Us:SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.Job Summary: The Senior Validation Engineer will be responsible for validating/qualifying systems, equipment, processes, and facility utilities, in order to meet regulatory requirements used for the manufacture of sterile products within a GMP environment. Ensuring that Validation and Qualification procedures and day to day activities are aligned with company specifications and current regulatory requirements.Essential Job Duties and Responsibilities:Develop, review, and execute validation protocols (IQ/OQ/PQ) for fill/finish equipment, utilities, and processes, including aseptic filling lines, autoclaves, and packaging systems.Perform validation and qualification of computerized systems and ensure compliance with 21 CFR Part 11 and data integrity principles.Establish and maintain the validation master plan (VMP), and ensure periodic review of validated systems.Experience with aseptic processing equipment (filling lines, isolators, lyophilizers, depyrogenation tunnels), clean utilities (WFI, compressed air, nitrogen), and environmental monitoring systems.Perform risk assessments and develop validation plans to ensure compliance with industry standards.Analyze validation data and prepare comprehensive validation reports.Write and update reports, procedures, and policies.Responsible for accuracy and compliance with validation and equipment records. Effectively plan, schedule, and prioritize validation projects to meet business goals and deadlines. Manage and/or perform revalidation, engineering studies to evaluate new products or components. Change control assessments, investigations and coordination of computer and method validations of applicable products. Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols.Collaborate with cross-functional teams to optimize validation processes.Provide staff training and guidance on validation principles, processes, and regulations. Proactively address validation issues, deviations and nonconformities, implementing corrective actions. Compliance with all applicable OSHA standardsOther job duties as assigned. Essential Qualifications:Bachelor's degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university. Minimum 3 years of validation experience or related quality experience in GMP Device or Drug environment. Demonstrated experience of regulated industry validation lifecycle activities may also be acceptable. Experience of leading validation deviation and change control procedures.Desirable Qualifications:Demonstrated ability to manage multiple projects and competing priorities preferred. ADA Requirements:Stand, walk, bend, squat, twist, reach or otherwise move frequentlyOccasional repetitive motion and graspingOccasional climbing to reach areas on machines or racksLift, move or otherwise transfer up to 50 lbs. occasionally, >20 lbs. frequentlyTypically sits, grasps items or performs keyboarding for occasional operation of a computerAt SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job.  If your experience is close to what you see listed here, please still consider applying.  We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify.Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.#IND#LI-RL1