Tech Services Representative (Weekend Shift, Friday - Monday, 08:30-19:00)

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 Technical Services Floor Support Representative is a member of the Technical Transfer Team (MSAT) that provides onsite processing support to Manufacturing. This position is 100% onsite at the Bloomington facility and reports to the Sr. Manager, Technical Transfer. This role is a full-time weekend position that works Friday to Monday (4 x 10 hrs).

The 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

Required qualifications:

• BS/BA degree, preferably in the science or engineering field, or 4+ years of Pharmaceutical Industry experience with a focus on formulation, filtration, and filling processes in lieu of education
• Knowledge of quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
• Knowledge of systems and equipment - including scales, mixing systems and mixing 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 creative 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, etc.)

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long periods of time in a classified environment
• Ability to qualify for Grades A, B, and 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

Pa…