Onsite Manufacturing Technical Services Specialist

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Paid Time Off

Education Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Manufacturing Technical Services Representative to lead master batch records, collaborate with cross-functional teams, and support client projects on-site at the Bloomington facility.

The role emphasizes regulatory compliance, quality assurance, and process improvement with direct client interaction and on-site audits. Strong communication and organizational skills are essential.

Qualifications

• BS degree in a science-related field preferred, or 2-year degree plus 6 years of experience in aseptic pharmaceutical manufacturing in lieu of 4-year degree
• Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
• Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
• Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
• Ability to use enterprise software (i.e., JDE, Trackwise, etc.)

Responsibilities

• Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
• Review and release commercial batch records to production for execution
• Train manufacturing personnel on new and/or significant changes to MBRs
• Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)
• Authors technical studies in support of investigations or process improvements
• Own change controls and associated tasks
• Approve project related Bill of Materials
• Commercial contact for assigned internal and external clients
• Manages client project updates and reviews with all levels of management
• Participate (with assistance) in Business Review Meetings

Skills

Strong communication

Strong organizational skills

MS Office proficiency

Enterprise software familiarity

Education

Science-related BS degree

2-year degree +6 years aseptic pharma experience

Tools

JDE

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Manufacturing Technical Services Representative to lead master batch records, collaborate with cross-functional teams, and support client projects on-site at the Bloomington facility.

The role emphasizes regulatory compliance, quality assurance, and process improvement with direct client interaction and on-site audits. Strong communication and organizational skills are essential.