Pharma Manufacturing Process Expert (4x10 Onsite)

U469 (FCRS = US469) AAA USA Inc.; Indianapolis (IN); On-site; USD 85,000 - 159,000; Full time

Job summary

Novartis is seeking a Process Expert in Indianapolis to support manufacturing teams as a subject matter expert for product and process knowledge. You will help resolve issues, drive investigations to root cause, and ensure batches are manufactured safely and in compliance.

This role follows a 4x10 schedule (Mon-Thu, 10 hours) with onsite work. You will write and review master batch records and SOPs, participate in validations, and train production staff to uphold quality and continuous

Qualifications

• Bachelor's degree in Engineering, Pharmacy, or a related field.
• Minimum 3 years in a process support, shop-floor role within cGMP manufacturing or QA/QC.
• Strong understanding of pharmaceutical processes and GMP requirements.
• Excellent technical writing skills with documentation experience.
• Knowledge of RCA, CAPA, change control, and GDP.

Responsibilities

• Manage and maintain manufacturing documentation (MBRs, SOPs, risk assessments, protocols).
• Write and review manufacturing documentation (SOPs, batch records, white papers).
• Collect data for OPV, evaluate product performance, support CAPA.
• Lead investigations involving material transfer, API synthesis, formulation, filling, inspection, packaging.
• Ensure processes are inspection-ready and support optimization and new technology introduction.
• Review validation protocols and support process validations and short-term improvement projects.
• Provide guidance and training to production teams to drive processes to completion.

Skills

Technical writing

Root cause analysis

GMP knowledge

Investigations

Education

Bachelor's degree in Engineering, Pharmacy or related field

Job description

Novartis is seeking a Process Expert in Indianapolis to support manufacturing teams as a subject matter expert for product and process knowledge. You will help resolve issues, drive investigations to root cause, and ensure batches are manufactured safely and in compliance.

This role follows a 4x10 schedule (Mon-Thu, 10 hours) with onsite work. You will write and review master batch records and SOPs, participate in validations, and train production staff to uphold quality and continuous