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The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems.. Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee. Experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries. e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.. Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

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Job Summary - a Concise Overview Of The Job The Validation Engineer works alone and as part of the Engineering Department to author and execute IQ/OQ/PQ protocols, engineering studies, facility qualifications and other documents related to production and business systems. They will also be responsible for engineering and maintenance projects, such as repairs, upgrades or replacements as the need arises. They will work with quality, technical operations and production to identify and resolve issues. All incumbents are responsible for following applicable Division & Company policies and procedures. Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Engineering Services Operating unit for Chestnut Ridge site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities Engineering Services <ul><li>Adhere to all company and cGMP procedures as well as applicable safety regulations.</li><li>Author change controls, SOPs and protocols. </li><li>Protocols</li><li>Generates and executes validation protocols, and summarizes studies to ensure compliance with manufacturer and SPI specifications, with current Good Manufacturing Practices, and national standards</li><li>Responsible for confirming all communicated validation plans to applicable management</li><li>Provides technical assistance in the form of rationales or validation studies </li><li>Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.</li><li>Troubleshoots and resolves issues as needed </li></ul>Project Management <ul><li>Manage multiple projects with competing deadlines</li><li>Manage external resources to complete tasks outside SPI’s capabilities</li><li>Manage approvers of documents and procedures and ensure timely closure of tasks</li><li>Manage project-related Change Requests form initiation through closure, including presentation to Change Control Committee</li><li>Assist with deviation investigation and identify areas for CAPAs as needed based on root causes.</li><li>Source and procure equipment, supplies and other materials as needed. </li><li>Develop and maintain cross-functional relationships </li></ul>Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job <ul><li>Bachelor of Science in Engineering or Science discipline preferred</li><li>Experience in pharmaceutical (i.e. Validation/QA or R&D), medical device, biotechnology industries </li></ul>Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. <ul><li>In-depth knowledge of the pharmaceutical plant operations is an asset </li></ul>Skills & Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. <ul><li>Proficient in Microsoft Word, Excel, Power Point, Project, AutoCAD and other software relevant to the performance of the Job</li><li>Experience authoring change controls in Trackwise or other quality management system</li><li>Experience authoring SOPs in MasterControl or other document management system</li><li>Integrity – Works with integrity and ethically; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.</li><li>Collaboration – Works well in group problem solving situations; Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions. </li><li>People – Treats people with respect; Keeps commitments; inspires the trust of others; Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; promotes a harassment-free environment.</li><li>Responsive – Identifies and adapts to priority issues as they arise; Communicates with management and team members effectively; Works quickly and efficiently </li><li>Proactive – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.</li><li>Organized – Tracks deadlines and adheres to schedules; Writes clearly and informatively; Presents numerical data effectively.</li><li>Learning Mindset – Adapts to unfamiliar situations as needed; Open to new ideas and methods; Readily familiarizes self with new equipment and processes </li></ul>Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process</li></ul>

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