Technical Services Representative - Weekend Shift (9pm-7:30am)

Job Description

Simtra BioPharma Solutions is seeking a Technical Services Representative to join their Technical Transfer Team. This role is crucial for providing onsite support to manufacturing operations at the Bloomington facility. The Technical Services Representative will report to the Sr. Manager, Technical Transfer, and will work on the 2nd shift.Responsibilities include:

• Making and delivering accurate and timely decisions pertaining to projects, questions, and requests
• Escalating issues to impacted departmental manager, project owner, and/or Director as necessary for corrective action implementation
• Partnering 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
• Providing expertise in aseptic processing
• Evaluating product impact and advising if product meets release criteria per regulatory constraints
• Understanding the technical requirements of each project
• Understanding the Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product

Qualifications include:

• 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.)

Simtra BioPharma Solutions offers:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Employee Ownership Plan
• Voluntary Insurance Benefits
• Onsite Campus Amenities