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 Position

  The validation department consists of four teams; Equipment/Facility, Process, Cleaning and Computer System Validation (CSV). The equipment/facility team initially qualifies and maintains the qualified state of all equipment, facilities and utilities. The process team facilitates at-scale mixing and hold studies, qualifies new products, and maintains the media fill program. The cleaning group qualified equipment used to remove product from manufacturing parts, qualified cleaning methods and performed routine TOC testing. The CSV group qualifies new computer systems and changes to computer systems. All teams support the manufacture of pharmaceutical products and often require direct contact with clients and internal customers across the site. Successful candidates will have excellent communication skills, be self-motivated and action oriented. This department requires individuals to independently problem solve, take ownership of their projects and drive to meet deadlines. There is significant opportunity to learn, try new things and personally impact the business, our clients and ultimately patients taking the life-saving products we manufacture.

  Relationships

  Reports to: Validation Manager

  Essential Functions

• Equipment Validation:

• Lead execution validation protocols including installation / operational qualifications and requalification’s on process equipment and utilities

• Revise validation documents including protocols and SOPs

• Access data and generate reports from control systems

• Compile data for qualification reports; complete and review calculations and perform technical review of validation documents

• Lead investigations, change controls, and similar activities

• Draft new protocols for systems similar to existing site systems

• Develop qualification strategies and documents for novel systems

• Present qualifications to clients, auditors, and inspectors

• Coordinate with other internal groups including QC, engineering, automation, and production to complete execution of validation protocols and other tasks

• Demonstrate familiarity with industry guidance documents for equipment validation

• Execute validation tasks and projects to achieve project timelines

• Review work orders and similar records for validation impact

• 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

• Lead complex equipment validation projects

• Review and approve deviations relevant to equipment validation

• Understand other validation technical disciplines, such as cleaning, computer system validation, and process validation, and be able to integrate equipment validation into broader projects

• Aware of regulatory trends, industry best practices, and technological improvements related to equipment validation

• Lead response to regulatory requests and observations

• Computer System Validation:

• Execute computer system validation protocols

• Compile data for qualification reports; complete and review calculations and perform technical review of validation documents

• Lead investigations, change controls, and similar activities

• Participate in generating system lifecycle documentation, including requirement specifications, risk assessments, criticality assessments, and trace matrices

• Present qualifications to clients, auditors, and inspectors

• Coordinate with other internal groups including QC, engineering, automation, and production to complete execution of validation protocols and other tasks

• Execute validation tasks and projects to achieve project timelines

• Familiar with areas of computerized systems process automation code (e.g., ladder logic or g-code), network architecture, databases, automated instrumentation, and/or application programming; able to develop risk-based qualification strategies for systems in the areas of competence

• Develop qualification strategies and documents for novel systems

• 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

• Competent in multiple system types

• Mastery of GAMP principles and compliance

• Participate in response to regulatory requests and observations

• Review and approve deviations relevant to computer system validation

• Understand other validation technical disciplines, such as equipment validation, cleaning validation, and process validation, and be able to integrate computer system validation into broader projects

• Aware of regulatory trends, industry best practices, and technological improvements related to computer system validation

• Lead response to regulatory requests and observations

• Process Validation:

• Write and execute process validation protocols and reports

• Write and revise validation documents including protocols, reports, and SOPs with guidance from Engineers and/or Supervisor

• Access data and generate reports from control systems

• Compile data for qualification reports; complete and review calculations and perform technical review of validation documents

• Lead investigations, change controls, and similar activities

• Lead client meetings for product introduction and lifecycle management

• Write process validation protocols and reports

• Participate in generating process lifecycle documentation, including specifications, risk assessments, and trace matrices

• Present qualifications to clients, auditors, and inspectors

• Develop qualification strategies and documents for novel processes

• 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, and other industry organizations

• Formal client communications including client memos as required for process validation topics

• Review change controls for process impact

• Lead client meetings and response to client and regulatory requests and observations

• Review and approve deviations relevant to process validation

• Understand other validation technical disciplines, such as equipment validation, cleaning validation, and aseptic process simulation, and be able to integrate computer system validation into broader projects

• Aware of regulatory trends, industry best practices, and technological improvements related to computer system validation

• Review new product introductions and perform validation evaluations

• Lead response to client and regulatory requests and observations

• General Responsibilities (All Disciplines):

• Assists with maintaining Commissioning, Qualification, and Validation Master Plans and supporting procedures in alignment with industry standards and corporate policies

• Drafts and executes plans, protocols, and reports related to commissioning, qualification, and validation of simple systems and processes. This includes associated protocol events

• Maintains systems and processes in the qualified and/or validated state, including performing requalifications and periodic reviews

• Participates on cross functional teams to support initiatives around qualified and/or validated systems and processes

• Oversees validation contractors with oversight from management

• Provides technical assistance to personnel

• Files and maintains controlled documents

• Other duties as assigned

  Qualifications

• Education/Experience:

• Bachelor’s degree or higher in a STEM discipline, required

• Master’s/PhD or Certificate (i.e. PE), preferred

• 8+ years of Validation experience

• 4 years GMP or regulated industry experience, required

• Must be able to read and understand English-written job instructions and safety requirements

• Technical Requirements:

• Ability to use Excel, Word, and other office systems

• Ability to learn and use quality management software such as TrackWise® or ComplianceWire®

• Ability to understand and independently apply CGMPs to everyday work

• Demonstrates understanding of the work tasks assigned

• Executes procedures of moderate complexity with high quality

• Intermediate understanding of pharmaceutical laboratory and/or production operations

• Capable of learning unfamiliar principles or techniques with training

• Ability to contribute to investigations, deviations, and change controls with initial consultation from supervisor

• Ability to problem solve and execute and monitor corrective actions

• Ability to interpret data and analyze trends to provide insight into potential issues

• Edits Standard Operating Procedures (SOPs) and reports with guidance from supervisor

• Seeks best practices for daily work activities

• Behavioral Requirements:

• Ability to see and hear and read and write clear English

• Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner

• Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time

• Ability to cooperate with coworkers within an organized team environment or work alone

• Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines

• Ability to put aside personal opinions and focus on business needs, department needs or group needs

• Ability to transfer knowledge to others via training or mentoring

• Demonstrated ability to guide others thorough communication and learning

• Ability to make decisions which have moderate impact on immediate work unit

• Leadership Requirements:

• Builds on contacts and relationships with peers

• Take initiative for personal and professional development

• Takes initiative when necessary to address changes in scope and procedural errors

• Builds trust and respect for self and department

• 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.

  We 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.