Process Expert Job at Production Manufacturing, Indianapolis, IN

d2ZzYnRZWGV3VUNjWFRxWktPcUNjUEFXUUE9PQ==
  • Production Manufacturing
  • Indianapolis, IN

Job Description

Summary

As a Process Expert 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.

About the Role

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, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.
  • Ensure processes are 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.

Minimum Requirements:

  • Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
  • 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
  • Proven process understanding (Pharma, GMP, Regulatory aspects).
  • Strong awareness of quality issues.  Compliance investigations experience required.
  • Excellent technical writing skills

Desirable Requirements:

  • Previous Radio pharma experience a plus
  • Prior leadership and/or high cross-functional experience preferred.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Job Tags

Temporary work,

Similar Jobs

Medcadre Inc

Pharmacy technician Job at Medcadre Inc

 ...Job Title: Pharmacy Technician Location: Brooklyn, NY, 11235 Pay Range: $1050/week - $1190/week; $30/hr. - $35/hr. (based on...  ...week Benefits: Paid sick time Referral program Travel reimbursement Experience: ~ Pharmacy technician: 2 years... 

Fidelity Investments

Senior HashiCorp Vault Specialist Job at Fidelity Investments

 ...Information Systems/Science, or a related field. Over 5 years of experience and proven expertise in administering and operating the HashiCorp Vault application. Experience in systems and application management on Linux/UNIX platforms. Familiarity with cloud... 

Compose.ly

Education Website Writer Job at Compose.ly

 ...achievements, shares program information, and enhances community engagement. Profile Overview Client seeks a long-term content writer with a journalistic writing background, ideally with experience in education or nonprofit storytelling. The writer will help... 

Piggly Wiggly

Cashiers Job at Piggly Wiggly

 ...Responsibilities include: -Handling cash transactions with customers -Scanning goods...  ...Requirements: -Strong communication and time management skills -Customer satisfaction...  ...mathematical skills This position is part-time with comparable pay. Random Drug Testing... 

Avient Corporation

Manager, Manufacturing Job at Avient Corporation

 ...development of all manufacturing operations personnel. This includes safety, environmental, productivity, quality, maintenance, lean six sigma events and financial performance. Qualifications Bachelor's degree required At least 5 years' experience as a leader in...