US-GA, Sr Validation Engineer II SR0031229-MZ
Takeda is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics. Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest. This position supports site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines: Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation Cleaning validation Sterilization validation Process validation Provides technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. Individual must work on complex assignments, where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables. Independently designs, authors, executes and summarizes commissioning, qualification and/or validation studies. Partners with SMEs to ensure smooth and efficient execution of testing strategies. Collaboratively conducts risk and impact assessments. Supports development and review of standard operating procedures (SOP) and validation assessments. Interfaces with customers on technical issues, project timeline, and validation support. Actively participates on cross functional teams to determine the root cause and corrective actions for problems associated with investigations. Calculation and interpretation of data for commissioning, qualification and/or validation studies. Primary subject matter expert in audits and regulatory agency inspections. Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments. Demonstrates continuous improvement with respect to increasing job knowledge and proficiency related to validation in the biopharmaceutical industry, as well as technical understanding/problem solving capability. Manages successful completion of projects within boundaries of quality, time and budget. Based on significant technical expertise, reviews and approves complex design concepts. Recognized as expert by peers and other personnel within the business. Displays general understanding of theories/practices of a variety of disciplines. May lead a large-scale projects or several small projects with complex features. Leads large-scale projects or several small projects with complex features. Serves on Tier 2 work stream teams, as required. May perform other duties as assigned. Four-year college degree in engineering or science related curriculum required. A minimum of 10 years of relevant experience in a GMP regulated environment desired. At least 8 years of commissioning, qualification and validation (CQV) required. At least 2 years of personnel supervision experience desired. Validation and/or system experience in the following applicable areas: Sterilization and aseptic processing validation. Cleaning validation of manufacturing equipment. Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification. Technical understanding and experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results. Direct experience with manufacturing operations and biotechnology processes is strongly desired. Excellent communication and attention to detail skills. Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas. Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments. Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments. Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills. Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus. Complexity and Problem Solving Excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into manageable activities. Must possess basic knowledge of core principles in validation disciplines, as well as be experienced applying project management methodology. Knowledge of basic principles in various engineering disciplines. Internal and External Contacts Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation in support of execution activities. Interaction with project managers for schedule adherence.
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