About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around the world. What we offer you: + Leading pay and annual performance bonus for all positions + All employees enjoy generous paid time off including 14 paid holidays + Health Insurance, Dental Insurance, Vision Insurance – effective day one + Guaranteed 8% 401K contribution plus individual company match option + Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Shift Schedule: Monday-Friday, 8 AM - 5 PM Relationships Reports to Manager, Validation Essential Functions + Equipment Validation: + Develop qualification strategies and documents for novel systems + Evaluate change controls for equipment validation impact and determine required qualification activities + Train new team members and provide technical oversight of work performed by Technicians, Associate Engineers and/or Engineers + Strong understanding of guidance documents from FDA, EMA, PDA, ISPE, ASME, ISO, and other industry organizations + Participate in response to regulatory requests and observations + Cleaning Validation: + Develop qualification strategies and documents for novel systems and products + Computer System Validation: + Competent in multiple system types + Mastery of GAMP principles and compliance + Media Fill (APS) Validation: + Develop qualification strategies and documents for novel processes + Strong understanding of guidance documents from FDA, EMA, PDA, ISPE, and other industry organizations + Formal client communications including client memos as required for APS topics + Review change controls for APS impact + Lead response to client and regulatory requests and observations + Process Validation: + Formal client communications including client memos as required for process validation topics + Review change controls for process impact + General Responsibilities: + Supervises Validation personnel with oversight from management, including assignments and priorities, providing guidance, and serving as a resource for technical and administrative issues + Onboards, trains, motivates, and leads Validation personnel with oversight from management + Oversee complex equipment validation projects + Review and approve deviations relevant to validation + Develops and maintains Commissioning, Qualification, and Validation Master Plans and supporting procedures in alignment with industry standards and corporate policies + Provides guidance and oversight for commissioning, qualification, and validation of systems and processes + Drafts, reviews, and executes plans, protocols, and reports related to commissioning, qualification, and validation of systems and processes. This includes associated protocol events + Maintains systems and processes in the qualified and/or validated state, including performing and reviewing requalifications and periodic reviews + Reviews change controls to assess impact to commissioned, qualified, and validated systems and processes + Assists with validation topics during internal audits, including participating during audits, providing responses to audit observations, and completing corrective actions + Serves as a quality contact and subject matter expert (SME) for simple qualified and/or validated systems and processes + Implements improvements to established systems, processes, procedures, etc. to support quality management systems with oversight from management + Leads cross functional teams for initiatives around simple qualified and/or validated systems and processes + Independently oversees validation contractors + Provides technical assistance and training to personnel + Files and maintains controlled documents + Leads team members to improve and reinforce performance of others + Takes responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly + Works with, coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development + Follow all safety and environmental requirements in the performance of duties + Other duties as assigned Physical Requirements Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed. Development Of People Supervisory. Qualifications + High School/GED and 6+ years of relevant experience, required OR Bachelor’s degree in STEM field, required + 0-1 years of relevant leadership experience + 1-year GMP or other regulated industry experience, required Must be able to read and understand English-written job instructions and safety requirements + Technical Requirements: + Excellent written and verbal communication skills with internal and external customers + Ability to communicate complex technical information to non-technical audiences + Maintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelines + Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution + Able to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertise + Begin to provide reliable and defendable interpretations of regulatory guidance for the customer + Well organized with ability to handle and direct multiple activities within the group simultaneously + Behavioral Requirements: + Positions views and arguments appropriately to win support + Convinces others to take action + Negotiates professionally in tough situations + Wins concessions without damaging relationships + Responds effectively to the reactions and positions of others + Understands internal and external stakeholder requirements, expectations, and needs + Balances the interests of multiple stakeholders within team + Acts fairly despite conflicting demands of stakeholders (client programs and team) + Leadership Requirements: + Uses comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead projects within a department, group, or team in a single function or focus + Applies technical and functional knowledge to design projects that contribute to overall direction of department or discipline + Manages day to day activities with individual team + Focuses on and regularly communicates to team about team priorities and sets aside identified less critical tasks + Makes implementation plans and assignments that allocate resources appropriately to complete objective + Looks for obstacles and develops effective contingency plans with input for department initiatives and team's projects + Uses milestones to diligently track and manage the progress of the team and own work + Maintains staff by recruiting and hiring employees, developing personnel growth opportunities, supporting employee motivation, and providing strategic alignment with Quality Assurance Department and site initiatives + Establishes an effective, professional, and positive relationship with employees + Clarifies responsibilities and expectations and holds employees accountable + Participates in and conducts timely HR-related processes + Provides timely constructive feedback that is clear and direct + Provides guidance on how to strengthen knowledge, skills, and abilities to improve personal and organizational performance + Uses appropriate methods and flexible interpersonal style and coaching to develop others’ capabilities + Recognizes and reinforces developmental efforts, progress, and improvements + Collaboratively works with direct reports to set meaningful performance objectives We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.