Manufacturing Technical Services Representative Simtra US LLC life insurance, parental leave, paid time off, paid holidays, 401(k) United States, Indiana, Bloomington 927 South Curry Pike (Show on map) Sep 10, 2026 Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering 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

• which are all directly injected into patients worldwide.

As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra?

Because we:

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, their patients, and our team members. Make it COUNT
• We take pride in our day-to-day work, knowing the impact we make
• 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 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.

The 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
  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 responsible for advising if product meets release criteria
  Use knowledge of manufacturing systems and equipment to write batch record and perform other duties
  Understands 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 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.) 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

Employee Ownership Plan 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. Data Privacy To learn more about Simtra's approach to data privacy, please review the

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