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 life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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 Validation strategy is to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation and to ensure the validation deliverables meet the quality standards and requirements of company policies and FDA regulations. Responsibilities include managing multiple projects to provide documented validation of equipment, control systems, CGMP utilities and manufacturing processes, establishing philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures, managing the activities of direct reports to accomplish scope of work of validation department, managing protocol and report development, execution and approval associated with commissioning and validation, cleaning validation and process validation, reviewing and approving facility equipment and software changes, evaluate and determine required validation testing, coordinating contract commissioning and validation services including contract review and approval, and overseeing the implementation of laboratory validation requirements.
The Position
Relationships
Reports to : Senior Manager or above
Direct Reports : 5 – 12
Essential Functions
Media Fill Validation :Lead, design, execute, and analyze media fill simulations to qualify aseptic filling operations within isolators, ensuring compliance with regulatory and quality standards (FDA, EU GMP)
Oversee all aspects of aseptic filling operations, ensuring the sterility of product environments, implementing contamination control strategies, and maintaining operational excellence in isolatorsBuild aseptic team oversight of the filling processesUtilize microbiological knowledge to develop contamination control strategies, interpret / support microbiological results from media fills, environmental monitoring, and sterility testingEnsure that applicable aseptic processing activities are compliant with current Good Manufacturing Practices (cGMP), ISO standards, and regulatory agency requirementsLead and mentor a team of aseptic processing and microbiology professionals, ensuring proper training and performance in aseptic techniques and isolator operationsPrepare and maintain detailed reports of media fill results / reports, environmental monitoring data, and aseptic process validationIdentify opportunities for process improvement in aseptic techniques, isolator efficiency, and overall contamination control strategies. Implement best practices and corrective actionsPerform risk assessments related to aseptic processing, media fills, and microbial contamination Develop mitigation strategies for potential sterility risksParticipate in regulatory audits, internal audits, and inspections related to aseptic processing, media fills, and microbial controlDevelop qualification strategies and documents for novel processesTrain new team members and provide technical oversight of work performed by Technicians, Associate Engineers and / or EngineersStrong understanding of guidance documents from FDA, EMA, PDA, ISPE, and other industry organizationsFormal client communications including client memos as required for APS topicsReview change controls for APS impactLead response to client and regulatory requests and observationsOther duties as assignedGeneral Responsibilities :Supervises Validation personnel with oversight from management, including assignments and priorities, providing guidance, and serving as a resource for technical and administrative issues
Oversee complex equipment validation projectsReview and approve deviations relevant to validationUnderstand all validation technical disciplines, including equipment, cleaning, computer system validation, and process validation, and be able to integrate validation into broader projectsAware of regulatory trends, industry best practices, and technological improvements related to equipment validationParticipate in new product introduction, deviation reviews, and other systems as senior SME for validationLead response to regulatory requests and observations as requiredOnboards, trains, motivates, and leads Validation personnel with oversight from managementDevelops and maintains Commissioning, Qualification, and Validation Master Plans and supporting procedures in alignment with industry standards and corporate policiesProvides guidance and oversight for commissioning, qualification, and validation of systems and processesDrafts, reviews, and executes plans, protocols, and reports related to commissioning, qualification, and validation of systems and processes. This includes associated protocol eventsMaintains systems and processes in the qualified and / or validated state, including performing and reviewing requalifications and periodic reviewsReviews change controls to assess impact to commissioned, qualified, and validated systems and processesAssists with validation topics during internal audits, including participating during audits, providing responses to audit observations, and completing corrective actionsServes as a quality contact and subject matter expert (SME) for simple qualified and / or validated systems and processesImplements improvements to established systems, processes, procedures, etc. to support quality management systems with oversight from managementLeads cross functional teams for initiatives around simple qualified and / or validated systems and processesIndependently oversees validation contractorsProvides technical assistance and training to personnelFiles and maintains controlled documentsLeads team members to improve and reinforce performance of othersTakes 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 promptlyWorks with, coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career developmentOther duties as assignedPhysical 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.
Qualifications
Education / Experience :Bachelor’s Degree, required
Master’s Degree, preferred3-5 years of relevant leadership experience5 years GMP or other regulated industry experience, requiredMust be able to read and understand English-written job instructions and safety requirementsTechnical Requirements :Excellent written and verbal communication skills with internal and external customers
Ability to communicate complex technical information to non-technical audiencesMaintains data integrity and ensure compliance with company SOP’s, specifications, as well as cGMP, ICH, FDA, EMA regulations or guidelinesAble to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolutionAble to combine and interpret data from multiple disciplines and an understanding of the full Biologics process with respect to specific area of expertiseBegin to provide reliable and defendable interpretations of regulatory guidance for the customerWell organized with ability to handle and direct multiple activities within the group simultaneouslyBehavioral Requirements :Positions views and arguments appropriately to win support
Convinces others to take actionNegotiates professionally in tough situationsWins concessions without damaging relationshipsResponds effectively to the reactions and positions of othersUnderstands internal and external stakeholder requirements, expectations, and needsBalances the interests of multiple stakeholders within teamActs 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 disciplineManages day to day activities with individual teamFocuses on and regularly communicates to team about team priorities and sets aside identified less critical tasksMakes implementation plans and assignments that allocate resources appropriately to complete objectiveLooks for obstacles and develops effective contingency plans with input for department initiatives and team's projectsUses milestones to diligently track and manage the progress of the team and own workMaintains staff by recruiting and hiring employees, developing personnel growth opportunities, supporting employee motivation, and providing strategic alignment with Quality Assurance Department and site initiativesEstablishes an effective, professional, and positive relationship with employeesClarifies responsibilities and expectations and holds employees accountableParticipates in and conducts timely HR-related processesProvides timely constructive feedback that is clear and directProvides guidance on how to strengthen knowledge, skills, and abilities to improve personal and organizational performanceUses appropriate methods and flexible interpersonal style and coaching to develop others’ capabilitiesRecognizes and reinforces developmental efforts, progress, and improvementsCollaboratively works with direct reports to set meaningful performance objectivesWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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.
