Onsite Manufacturing Technical Specialist – MBR & Process

Simtra US LLC; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Paid Holidays

Paid Time Off

Adoption Reimbursement

Education Assistance

Employee Assistance Program

Disability Insurance

Vision Coverage

Critical Illness Insurance

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Manufacturing Technical Services Representative for on-site work. You will own MBRs, release batches, and train personnel on MBR changes while coordinating with QA, manufacturing, and program management to ensure quality and timely project delivery.

The role requires a BS in science, strong communication and organizational skills, familiarity with quality/regulatory requirements, and proficiency in Microsoft Office and enterprise

Qualifications

• BS degree in science; familiarity with quality operating procedures and regulatory requirements for pharmaceutical/biological quality.
• Strong written and verbal communication; capability to interact across functions and levels.
• Solid organizational skills, attention to detail, and ability to manage multiple projects with tight deadlines.
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Ability to use enterprise software (e.g., JDE, TrackWise, etc.).
• Ability to qualify for Grade C areas.

Responsibilities

• Own and serve as technical expert for commercial master batch records (MBR) for assigned projects – author, maintain, revise MBRs.
• Review and release commercial batch records to production for execution.
• Train manufacturing personnel on changes to MBRs.
• Investigate Non-Conformance Reports (NCR) and determine root cause to assign corrective actions.
• Author technical studies in support of investigations or process improvements.
• Own change controls and related tasks.
• Approve project-related Bills of Materials.

Skills

Communication skills

Organizational skills

MS Office

Interdepartmental collaboration

Quality systems

Education

BS degree in science

Tools

JDE

TrackWise

ERP systems

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Manufacturing Technical Services Representative for on-site work. You will own MBRs, release batches, and train personnel on MBR changes while coordinating with QA, manufacturing, and program management to ensure quality and timely project delivery.

The role requires a BS in science, strong communication and organizational skills, familiarity with quality/regulatory requirements, and proficiency in Microsoft Office and enterprise