Tech Services Representative (Weekend Shift, Friday Monday, 0830-1900)

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 youll be eligible for1:

• 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
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

1 Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

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