Manufacturing Technical Services Representative

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 (Simtra) is a world‑class Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – all directly injected into patients worldwide. We hold ourselves to the highest quality and regulatory standards, emphasizing continuous improvement at Simtra.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.

Why join Team Simtra?

• Make it HAPPEN – we bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER – we work as one, respecting each voice and tapping into our unique strengths across teams so we can solve problems in new ways.
• Make it RIGHT – we hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, patients and our team members.
• Make it COUNT – we take pride in our day‑to‑day work, knowing the impact we make by taking on challenges big and small to improve patient health.

This role

The Manufacturing Technical Services Representative is a member of the core client team, interacts directly with clients, and 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 of Manufacturing Technical Services.

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 Reports (NCR) and determine root cause to assign or own corrective action(s).
• Author technical studies in support of investigations or process improvements.
• Own change controls and associated tasks.
• Approve project‑related Bill of Materials.
• Act as 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.
• Evaluate non‑conformance situations for product impact and advise if product meets release criteria.
• Use knowledge of manufacturing systems and equipment to write batch record and perform other duties.
• Understand the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), regulatory and procedural requirements that govern the client/company relationship and product.

Required qualifications

• 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, Outlook).
• Ability to use enterprise software (e.g., JDE, Trackwise, etc.).
• Ability to qualify for Grade C areas.

Physical / safety requirements

• 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.

In return, you'll be eligible for [1]

• 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.

Disclaimer

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.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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