Onsite MSAT Tech Services Floor Support (Weekend)

Simtrabps; Bloomington (IN); On-site; USD 33,062 - 44,083; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 4%

Time Off Program (Paid Holidays, PTO)

Paid Parental Leave and more

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities: Workout/ Caf?

Job summary

Simtra in Bloomington, IN is seeking a Technical Services Floor Support Representative, a 100% onsite weekend role (Fri-Mon, 4x10h, 08:30–19:00) within the Technical Transfer Team (MSAT). You will make timely decisions, support QA/QC/Manufacturing, and assist with deviation investigations and aseptic processing.

You will collaborate across functions, ensure regulatory alignment, and navigate Master Batch Records and related documents while supporting multiple projects and tight deadlines.

Qualifications

• BS/BA in science or engineering, or 4+ years pharma experience in formulation, filtration, and filling.
• Knowledge of quality operating procedures and regulatory requirements in pharma, biological and biochemical quality.
• Knowledge of systems and equipment— including scales, mixing systems and monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends.
• Ability to be a self‑starter and work independently on projects and tasks.
• Ability to use critical thinking and problem‑solving skills.
• Ability to write and perform Technical Services Studies (TSS).
• 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.
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, Outlook) and MiniTab.
• Ability to use and understand enterprise software (i.e., D365, BPLM, Pilgrim, Trackwise).

Responsibilities

• Responsible for making and delivering accurate and timely decisions pertaining to projects, questions, and requests.
• Escalates issues to impacted departmental manager, project owner, and/or Director as necessary for corrective action implementation.
• Partners with Quality Assurance Associate, Quality Control Representative and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent information.
• Deviation investigation writing with assistance.
• Filter troubleshooting and testing, including PUPSIT.
• Ability to provide expertise in aseptic processing.
• Capable of evaluating product impact and responsible for advising if product meets release criteria per regulatory constraints.
• Understands the technical requirements of each project.
• Understands the Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product.

Skills

Strong communication skills

Self-starter

Critical thinking

Problem-solving skills

Ability to work independently

Attention to detail

Education

BS/BA in science or engineering

4+ years pharma experience

Tools

MS Office Suite

MiniTab

D365

BPLM

Pilgrim

Trackwise

Job description

Simtra in Bloomington, IN is seeking a Technical Services Floor Support Representative, a 100% onsite weekend role (Fri-Mon, 4x10h, 08:30–19:00) within the Technical Transfer Team (MSAT). You will make timely decisions, support QA/QC/Manufacturing, and assist with deviation investigations and aseptic processing.

You will collaborate across functions, ensure regulatory alignment, and navigate Master Batch Records and related documents while supporting multiple projects and tight deadlines.