Senior Validation Engineer - Miami

Job Description

How will you make an impact?Senior Validation Engineer participates as an active member of a dynamic team with high involvement and engagement in powder and liquid cell culture manufacturing operations. Supports the Manufacturing, Quality, and Practical Process Improvement (PPI) programs within the Advanced Bioprocessing site in Miami, Florida, leading projects of cross-functional groups including internal sites, departments, and contractors / vendors.What will you do?Adhere to site validation master plans by consistently completing validations on time. Execute validation projects to ensure facility and utility systems, manufacturing equipment and processes, computer systems, laboratory equipment and test methods are validated in accordance with established regulations and approved site and corporate standards.Create and execute protocols in support of new equipment, process automation, analytical methods, and cleaning.Provide direction to engineering firms and vendors in the design and qualification of facilities and equipment.Assist in the development and review of new product introductions, technical transfer project documentation, and external presentations / publications. Effectively liaison with representatives from originating / sending sites, R&D, Quality Control, Manufacturing, etc. to ensure design and readiness for manufacturability. Perform laboratory test method validations, verifications, and transfers to support NPI / transfer projects.Provide support in the area of troubleshooting of new and existing equipment, processes, and test methods. Participate in Engineering/Optimization studies to support validation execution.Participate in Quality, Engineering, and Production functions to achieve the overall objectives of the site.Support Change Control systems. Review change management requests and assess for validation impact. Execute annual and semi-annual re-qualification activities and following changes to facilities, equipment, processes, etc.Analyze information related to the overall performance of manufacturing processes, equipment and support systems to activate re-validation activities or initiate PPI/CI projects.Create detailed work instructions, standard operating procedures, and ability to train functional areas and end users.Provide education, training, and assistance to those who participate in validation activities.Assure compliance to appropriate regulatory requirements. Initiate quality records when not in compliance and inform Quality of noncompliance and proposed corrective activities.Assure validation support structure and document handling systems are maintained.Create technical process documents that fit the business needs and maintain compliance with internal and external requirements.Make effective decisions relative to position requirements.Work with functional teams to achieve operational goals.Communicate issues and concerns to management.Back-up support to Validation Manager.EducationBachelors Degree in Science or Engineering is required.ExperienceMinimum of 8 years of validation experience in Pharmaceutical / Biotechnology industry.Experience with aseptic processing / systems and sterilization processes preferred.Experienced in new product introductions, technical process and method transfers.Project management experience and the ability to organize and manage projects and coordinate the efforts of multiple groups within different companies / divisions. Ability to influence without authority to achieve project objectives.Knowledge, Skills, AbilitiesThorough knowledge of quality management systems and validation principles for manufacturing processes and laboratory test methodologies, engineering design fundamentals, regulatory agency expectations, and industry trends.Hands-on experience in validation protocol generation and execution for equipment, computer systems, and analytical methods.Capable of independently applying validation principles to projects, review and approval of documents, and problem resolution.Knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications.Sufficient knowledge of chemistry, microbiology, and other sciences to effectively meet the responsibilities of the position.Possesses technical and analytical skills to be able to lead root cause investigations in a timely and effective manner.Strong technical writing, effective verbal communication, and interpersonal skills.Ability to prioritize and perform multiple tasks, with minimal supervision required.Ability to work in teams to obtain results, self-motivated, and ability to effectively manage conflict.Working competency of: Microsoft Word, Excel, Power Point, Project, and statistical programs.Certified Six Sigma Green Belt or equivalent preferred.Must be flexible to meet requirements of qualification work schedules.Apurva 
703-889-6588
ApurvaS@Lancesoft.com