MSAT Tech Services Representative (Weekend Day Shift, Friday - Monday)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Co

Paid Holidays

Paid Time Off

Paid Parental Leave and more

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Technical Services Floor Support Representative to join the MSAT team for 100% onsite support. The role is a full-time weekend position, Fri–Mon, four 10-hour days, reporting to the Sr. Manager, Technical Transfer.

You will support aseptic processing, participate in deviation investigations, and coordinate with QA/QC and Manufacturing to meet regulatory release criteria.

Qualifications

• BS/BA degree in science or engineering or 4+ years of pharmaceutical experience.
• Knowledge of quality operating procedures and regulatory requirements.
• Knowledge of systems and equipment including aseptic formulations and QC/QA.
• Ability to work independently on projects and tasks with strong problem solving.
• Strong written and verbal communication across multiple functions.

Responsibilities

• Make and deliver accurate decisions for projects, questions, and requests.
• Escalate issues for corrective action to the appropriate manager or director.
• Coordinate with QA/QC and Manufacturing to align projects and information.
• Assist with deviation investigations and TSS studies.
• Troubleshoot and test, including PUPSIT, and provide aseptic processing expertise.
• Evaluate product impact and advise on release criteria per regulatory constraints.

Skills

Quality procedures knowledge

Critical thinking

Problem solving

Technical communication

Independent work

Microsoft Office Suite

Minitab

Enterprise software literacy

Education

BS/BA in science or engineering

Pharmaceutical industry experience (4+ years)

Tools

MS Office Suite (Word, Excel, Outlook)

MiniTab

D365

BPLM

Pilgrim

Trackwise

Job description

Bloomington, Indiana, United States

Technical Services Floor Support Representative

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, 08:30‑19:00).

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

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

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.

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.