Specialist II, Formulation / Filling

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.

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:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance - effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. 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

In general, this position provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner.

Relationships

Reports to Senior Manager, Form/Fill

Essential Functions

In general, this position's primary duty is to support an assigned production area regarding process control, including data collection and metric reporting

Collect and/or enter departmental data regarding the performance of people, processes, and equipment

Organize and/or create visual representations (spreadsheets, reports, slide shows, etc.) of data for multiple audiences

Complete projects and special assignments by establishing objectives, determining priorities, managing time, gaining cooperation of others, monitoring progress, problem solving and adjusting plans

Improve quality results by studying, evaluating, and redesigning processes

Implement changes and manage visual communications

Has developed specialized skills or is multi-skilled developed through job-related training and considerable on-the-job experience

Completes work with a limited degree of supervision

Likely to act as an informal resource for colleagues with less experience

Suggests new, innovative solutions to problems

Coordinate with the engineering department and operations leadership to ensure equipment downtime is documented accurately within the Digital Factory system

Serves as the owner of the digital factory system for Drug Product - Secondary; educates leaders within the department, to include Room Leads and Supervisors, on digital documentation of production activities.

Serve as an Operations representative during weekly plan v actual analysis between operations and Supply Chain planners on schedule adherence and attainment plans and projections

Serve as a liaison between operations, engineering and Supply Chain Wizard personnel on process improvement initiatives, changes, and overall performance of the Digital Factory within Drug Product - Secondary

Perform Manufacturing review of all types of GMP Documentation including Master Batch Records, Engineering Studies, Logbooks, Forms, etc. to support timely release of material

Comprehensive understanding of required processing area in order to execute sufficient Manufacturing Review and materials evaluations

Properly document department corrections in appropriate corrections tracking systems

Proficient in GDP documentation

Interpret and Maintain manufacturing schedules as they pertain to specific area for the purpose of material readiness, and record review

Assists supply chain in inventory management in manufacturing areas including restock, expired materials, and availability

Comprehensive understand of JD Edwards as an inventory management system, and how it pertains to processing area

Comprehensive understanding of computer systems required to perform job functions (MES, JD Edwards, Power BI, Microsoft Office, LIMS)

Facilitate department meetings for deviation leveling, deviation review, and internal metrics review

Compilation and analysis of department metrics, as well as proposed changes in department processes based on out-of-trend results

Assists QA in driving timely batch release

Collaborates with Supervisors, Room Leads, QA to solve issues presented in BRs during Analyst review

Assists QA Batch Record Review with Client Observations, including priority observations from QA Client Support Team

Works with supply chain on proposed changes to re-order points, min/max, and MSS revisions

Assist in Track wise investigations

Proposes updates and clarifications to MS&T for batch records when issues and discrepancies are identified

Assists cross-functional departments in issues that pertain to analyst responsibilities

Sufficient understanding of several areas within manufacturing to support needs in other areas

Addresses corrections to all executed documentation in a timely manner to support lot release

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

• High School/GED required
• 5 years pharmaceutical and/or manufacturing experience required
• 5 years GMP experience
• Technical Requirements
• Proficient in Excel, Word, and other office systems
• Prior work experience with quality, operations and/or scientific management software such as TrackWise , ComplianceWire , JD Edwards , DeltaV , Chromatography (i.e. Unicorn ), etc.
• Ability to understand and independently apply CGMPs as it relates to clinical and commercial operations
• Demonstrates understanding of the work tasks assigned
• Executes complex with high quality
• Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines
• Intermediate understanding of pharmaceutical laboratory and/or production operations
• Capable of learning unfamiliar principles or techniques with training
• Prior experience leading deviation investigations using root cause analysis tools
• Champion change control and corrective / preventative actions
• Ability to interpret data and analyze trends and provide insight into potential issues and suggest solutions
• Authors and/or approves Standard Operating Procedures (SOPs), Batch Production Records (BPRs) and reports
• Ability to lead technical calls and discussions regarding investigations, audits, or other issues
• Seeks best practices for daily work activities
• Ability to support Risk Assessments, especially Hazard Analysis, Fault Tree Analysis, FMEA, etc

Behavioural 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

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

Leads by example according to the Company's values and culture

Builds on contacts and relationships with peers

Takes 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 . click apply for full job details