Technical Services Representative - Weekend Shift (7am-5:30pm)

Job Description

Simtra BioPharma Solutions is seeking a Technical Services Representative to join their Technical Transfer Team in Bloomington, Indiana. This is a 100% onsite, second shift position that reports to the Sr. Manager, Technical Transfer. Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market.This role involves:

• 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

Requirements 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
• Supplemental Life 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
• Workout Facility
• Cafeteria
• Credit Union