Technical Services Representative - Weekend Shift (Friday - Tuesday 2200 to 0830)

Simtra BioPharma Solutions•Bloomington, IN

23d•Onsite

About The Position

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 Representative is a member of the Technical Transfer Team that provides onsite support to manufacturing. This position is 100% onsite at the Bloomington facility and reports to the Sr. Manager, Technical Transfer.

Requirements

BS/BA degree, preferably in the science or engineering field
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., JDE, BPLM, Pilgrim, Trackwise, etc.)
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

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
Non-conformance report writing with assistance
Filter troubleshooting and testing
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