Engineer, Validation

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:

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 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.
The Position
Primary responsibility is to provide validation services required for the successful delivery of process equipment and utilities.
Relationships
Reports to: Manager, Validation
Essential Functions

• Equipment Validation:
  • Lead validation protocols including installation / operational qualifications and requalifications on process equipment and utilities
  • Revise validation documents including protocols 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
  • Assist with investigations, change controls, and similar activities
  • Draft new protocols for systems similar to existing site systems
  • 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
  • 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
• Cleaning Validation:
  • Operate analytical equipment including TOC analyzers and conductivity meters
  • Execute validation protocols for cleaning method validation and cleaning process validation / revalidation
  • Support equipment holds and releases for cleaning
  • Compile data for qualification reports; complete and review calculations and perform technical review of validation documents
  • Assist with investigations, change controls, and similar activities

• Computer System Validation:
  • Execute computer system validation protocols
  • Compile data for qualification reports; complete and review calculations and perform technical review of validation documents
  • Assist with investigations, change controls, and similar activities
  • Perform cleaning validation carryover and limit calculations
  • Lead execution of analytical method validation for cleaning recovery methods (rinse and swabs)
  • Train and qualify personnel on cleaning swabbing methods
  • 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 cleaning validation
  • Execute validation tasks and projects to achieve project timelines
• Media Fill Validation:
  • Oversee Aseptic Process Simulation (APS) (media fill) executions to ensure compliance with the APS policy and procedures
  • Compile data for qualification reports; complete and review calculations and perform technical review of validation documents
  • Assist with investigations, change controls, and similar activities
  • Perform cleaning validation carryover and limit calculations
  • Lead execution of analytical method validation for cleaning recovery methods (rinse and swabs)
  • Train and qualify personnel on cleaning swabbing methods
  • 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 cleaning validation
  • Execute validation tasks and projects to achieve project timelines
  • Review work orders and similar records for validation impact

• Computer System Validation:
  • Execute computer system validation protocols
  • Compile data for qualification reports; complete and review calculations and perform technical review of validation documents
  • Assist with 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
  • Demonstrate familiarity with industry guidance documents for computer system validation including GAMP guidances
  • Execute validation tasks and projects to achieve project timelines
  • Familiar with 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 area(s) of competence
  • Strong understanding of GAMP compliance
• Media Fill Validation:
  • Oversee Aseptic Process Simulation (APS) (media fill) executions to ensure compliance with the Compile data for qualification reports; complete and review calculations and perform technical review of validation documents
  • Revise and update APS system documents including fill line matrices and routine reports
  • Assist with investigations, change controls, and similar activities
  • Participate in generating process lifecycle documentation, including specifications, risk assessments, and trace matrices
  • Present qualifications to clients, auditors, and inspectors
  • Revise and create APS validation documents including batch records, SOPs, and tech documents
  • Meet with clients to evaluate processes against existing qualified APS matrix

• Process Validation:
  • Execute process validation protocols
  • Revise validation documents including protocols, reports, and SOPs with
  • Access data and generate reports from control systems
  • Compile data for qualification reports; complete and review calculations and perform technical review of validation documents
  • Assist with investigations, change controls, and similar activities
  • Participate in 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
• 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 requalification 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

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.
Qualifications

• Education/Experience:
  • High School Diploma and 4+ years GMP experience, required OR
  • Bachelor's degree or higher in STEM discipline, required
  • Bachelor's degree required by May 2025
  • Master's degree or higher, preferred
  • 1-year GMP or other regulated industry experience, preferred
  • 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:
  • Lead by example according to Catalent's values and culture
  • 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

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.