Job Title Validation Engineer I Requisition JR000014275 Validation Engineer I (Open) Location Hobart, NY (Pharma) - USA036 Additional Locations Hobart, NY Equipment & Processes Maintained in a Validated State Assists with multiple cross-functional projects from development through release to production. Projects include new facilities startup, manufacturing equipment and packaging line FATs and qualifications. Independently executes activities in support of the Validation Department priorities with minimal guidance from the department manager. Provides technical assistance during investigations of equipment/process/product issues. Supports validation deviations related to equipment/process/product. Execute validations as needed, including assisting in product sampling, auditing and technical review functions as defined in study protocols. Analyzes data, utilizing appropriate statistical methods, generated by validation studies performed by the Validation group to determine process capabilities. Reviews and approves change control documentation to assure all validation requirements are detailed in the action items. Completes auditing and review activities including but not limited to recipe audits and equipment requalification assessment generation. Protocols & Reports Meet Organizational Requirements Develops protocols using engineering experience and statistical process controls. Prepares and maintains validation records in accordance with department procedures. Current with Industry Trends through Continuous Improvement Stays current with regulatory requirements and creates remediation plans. Drives continuous improvement to stay aligned with industry trends. Works cross-functionally with team, other departments, and corporate validation to support improvements. Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Experienced with using tools like FMEA as a risk based approach to determine and prioritize corrective actions. Minimum Requirements Education: Bachelor Degree in engineering discipline, life sciences or technical field related to pharmaceutical manufacturing is preferred or Associates Degree with equivalent combination of education, experience, and competencies accepted. Experience: 1-2 years of applied technical experience in Quality, preferably with previous validation experience in pharmaceutical manufacturing. Preferred Skills/Competencies: Experience with any combination of the following: equipment qualification, computer system validation, data integrity, cleaning validation and/or packaging validation. Strong technical and mathematical aptitude. Training or certifications in regulatory and cGMP requirements is desired. Familiar with FDA, USP, and ICH regulations and guidance. Strong computer literacy-MS office products, statistical analysis (Minitab) database usage. Knowledge of statistical process controls. Strong communication skills. Organizational Relationship/Scope: Action Oriented: Enjoys working hard; is action oriented and full of energy for the things he/she see as challenging; not fearful of action with minimized planning; seizes more opportunities than others. Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies. Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect. Organizing: Can marshal resources (people, finding, material support) to get things done; can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently; arranges information and files in a useful manner. Project Management: Manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives; achieves expected results through the successful and timely completion of activities; at the end of a project, with project team, takes time to determine what was learned that can be applied to future projects. Written Communications: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect. Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.