Manufacturing Specialist (weekend day shift)

Band

Level 3

Job Description Summary

This role is located on-site in Indianapolis IN. Novartis is unable to offer relocation support for this role : please only apply if this location is accessible for you.

Shift : Weekend Days - position may involve mandatory overtime as needed

As a Manufacturing Specialist you will provide front line support to manufacturing working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause and implementation of corrective and preventive actions.

Job Description

Major accountabilities :

• Manage and maintain manufacturing documentation including Master Batch Record applicable SOPs risk assessments protocols and other documentation as needed.
• Technical writing / Reviewing to support manufacturing operations including but not limited to Standard Operating Procedures (SOP) batch records and white papers.
• Collect data for ongoing process verification (OPV) support tracking and evaluation of product performance and implementation of CAPAs. Authoring / Owning investigations related to material transfer isotope manufacturing and packaging.
• Ensure processes remain inspection ready at all times.
• Support process optimization and new technology introduction for continued productivity improvement as appropriate.
• Review validation protocols and reports. Support the execution of process validations and short-term improvement projects.
• Provide guidance and support to production team through training and knowledge sharing.
• Will demonstrate leadership capabilities and guide processes to closure / completion while following all required guidelines and procedures.
• Participation in assigned qualification / validation activities as necessary.
• Facilitates a culture of speaking up and ensuring all cGMP compliance activities are followed.
• Prepares applicable documents and records such as batch records shipping documents and training materials.
• Participates in periodic mandatory overtime to ensure process continuity and completion.
• Other duties may be assigned as necessary.
• Ensure overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Essential Requirements :

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$77000.00 - $143000.00

Skills Desired

Change Control Chemical Engineering Continual Improvement Process Efficiency Employment Discrimination Flexibility General Hse Knowledge Good Documentation Practice Knowledge Of Capa Knowledge Of Gmp Lean Manufacturing Manufacturing Process Manufacturing Production Physics Process Control Production Line Productivity Risk Management Root Cause Analysis (RCA) Scheduler Technology Transfer Well-Being

Required Experience :

IC

Key Skills

Lean Manufacturing,Six Sigma,Continuous Improvement,ISO 9001,Lean Six Sigma,Management Experience,Manufacturing & Controls,5S,Manufacturing Management,Kaizen,Chemistry,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 77000 - 143000