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: Friday - Sunday, 8 AM - 8:30 PM
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
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-Valuate, identify, and implement improvements needed for processes and procedures
-Provide direct technical support for production processes and implementation of improvements
-Ownership of Corrective Actions, Change Management, Audit Support as SME, GMP and document revision, review and approval
-Lead and participate in continuous improvement process changes
-Has advanced and specialized expertise in an analytical/scientific method or operational process, typically developed through a combination of job-related training and considerable on-the-job experience
-Direct interaction with Client and Regulatory Auditors
-Lead and guide all tours related to client and regulatory audits
-Completes assignments and facilitates the work activities of others; may coordinate work beyond own area
-Proposes improvements to processes and methods
-Works autonomously within established procedures and practices
-Competent at-risk mitigation for function
-Write and revise SOP’s and WI’s
-Support or own work orders, deviations, and audit observations for equipment activities
-Provide training support for equipment set-up, operation, and changeover
-Actively participates, suggests solutions to problems, and drives to timelines
-Ensure documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities
-Create and assist in implementation of Corrective and Preventative Actions (CAPAs)
-Secondary
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-Has advanced and specialized expertise in an analytical/scientific method or operational process, typically developed through a combination of job-related training and considerable on-the-job experience
-Revise department documents, and route through EDMS
-Provides technical and floor support when required, and able to assist in basic troubleshooting of process and equipment
-Proposed process improvements and equipment improvements to MS&T, Engineering, and QA as applicable
-Collaborates with Supervisors, Room Leads, QA to solve issues real-time
-Executes other duties as assigned
-Drug Substance
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-Equivalent technical expertise of process and equipment with that of Senior Manufacturing Associate
-Review and Approve new client batch records
-Create, review, and revise process overviews, and process descriptions
-Supports training for new processes and procedures as it relates to new and existing customer programs
-Review and revise consumable designs and vendor drawings
-Work directly with vendors on design of new consumable items, as well as implementation at Company site (MSS creation, IM setup, etc.)
-Propose process improvements and equipment improvements to MS&T, Engineering, and QA as applicable
-Supports deviation investigators, and audit teams in CAPA implementation and creation
-Performs deviation investigations within TrackWise
-Drive strategic continuous improvement (CI) programs to optimize systems and processes within Manufacturing operations
-Provide executional feedback to PD and MS&T to drive revision of MBR's and continuous improvement
-Assist operators in with IT related issues, and offers suggestions for new/improved equipment
-Assist QA Batch Record Review with Client Observations, including priority observations from QA Client Support Team
-Provides on-call support for alarm management and troubleshooting, as necessary
-Creates and administers training content to elevate technical knowledge on team
-Works scheduled shift and other off-shift coverage as required
-Ability to read and write English
-Perform basic math skills (+, -, x, /, %, understand decimals)
-Required to read, understand, and follow GMP documents
-Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry)
-Works independently on limited scope issues
-In general, this position’s primary duty is to support an assigned production area regarding process control, including data collection and metric reporting
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-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
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-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
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-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
