Manufacturing Technical Services Representative

This role:

The Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.

• Owner and technical expert of commercial master batch records (M ) 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.
• Manage client project updates and reviews with all levels of management.
• Participate (with assistance) in Business Review Meetings.
• Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information.
• Participate on client calls and on‑site visits to discuss projects and issue resolutions.
• Participate (with assistance) in regulatory, client, and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations.
• Evaluates non‑conformance situations for product impact and is responsible for advising if product meets release criteria.
• Use knowledge of manufacturing systems and equipment to write batch records and perform other duties.
• Understands the Quality Agreement, Master Batch Record (M ), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product.

• BS degree, preferably in a science‑related field.
• 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.).
• Ability to qualify for Grade C areas.

• Duties may require overtime work, including nights and weekends.
• Position may require sitting or standing for long periods of time.
• Ability to qualify for Grade C areas.

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Additional Benefits
  • Short and Long‑Term Disability Insurance
• Voluntary Insurance Benefits
  • Vision Coverage
  • Accident
  • Critical Illness
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal and more
• Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

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