How This Role Makes a Difference

The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. 

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 Microbiology Technician is an entry-level position in the Microbiology lab.  This position works independently to perform routine sampling and process samples in support of the Microbiology department. This position reports to a Microbiology Supervisor.

The responsibilities:

• Samples controlled environments per the sampling Master Plan utilizing aseptic technique.
• Documents and processes samples in a Laboratory environment.
• Performs real time risk assessments of the manufacturing areas and process.
• Accurately distinguishes and counts microbial recoveries (mold and bacteria)
• Enters data into Laboratory Information Management System.
• Maintains data integrity and ensures compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements
• Will be required to recognize non-conformances.

Desired qualifications:

• High school diploma or GED.
• Prior experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, LIMS etc.)
• Must be able to communicate well. 

Physical / Safety Requirements:       

• Must be able to gown qualify for Grade A/B area.
• The position sometimes requires extended periods of standing.
• Must be able to wear applicable Personal Protective Equipment.
• Duties may require overtime work, including nights, holidays, and weekends
• Use of hands and fingers to manipulate office and laboratory equipment is required
• Must be able to lift 20 lbs
• Must be able to qualify for 20/25 corrected vision and pass color blindness test.

In return, you’ll be eligible for[1]:

• 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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

About the Job

We’re hiring an Equipment Technician who will focus on critical equipment to ensure that our clinical production team has everything they need to process and bank life-saving bone marrow.  In this role, you’ll be responsible for a variety of facility and equipment cleaning, maintenance, installation, operation, and troubleshooting to keep operations running smoothly in our cGMP (current Good Manufacturing Practice) facility.  This is a hands-on role, and we’ll train you on Good Documentation Practices, preparing tools for sterilization, and other support tasks which are key for a biotech manufacturing facility. Restocking materials and reagents as well as cleaning equipment/tools and autoclaving may also be a part of your daily routine.

This role reports to the Facilities Manager, and will work closely with both the Facilities team and the Clinical Production team.

Required Qualifications

• High School Diploma
• Ability to solve technical and performance problems using information from a variety of sources
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• This is an hourly, non-exempt role based in our Indianapolis facility
• We are currently hiring for Monday through Friday 8am - 5pm

Preferred Qualifications

• Experience working hands-on with laboratory/clinical equipment

Key Responsibilities

• Perform scheduled maintenance inspections and assurance inspections on equipment to ensure safe and effective operating conditions
• Assist with qualification of new equipment
• Test and calibrate components using a variety of manuals, troubleshooting techniques, and code requirements
• Perform routine preventative maintenance and calibrations of equipment
• Assist with cleaning, calibration, and maintenance of quality control, production, and research lab equipment, including non-routine maintenance and scheduling service or calibration with outside vendors as needed
• Assist in repair and replacement of complex medical equipment and systems
• Install and test a variety of medical and research equipment
• Diagnose equipment malfunctions with accuracy
• Perform activities in accordance with current GDP and cGMP 
• Recognize and communicate production and work environment issues/observations to supervisory staff in a timely manner

In your first six months some projects you’ll work on include:

• Training on gowning and cleaning practices for the cleanroom support areas
• Shadowing Clinical Production personnel and observe processing 
• Assisting Clinical Production team in developing improved tool cleaning procedures
• Learning the basics of safety, sterility, and the general flow of our methods and operations
• Understanding our freezers (-80° & -190°) and how they operate, fill and alarm
• Gaining familiarity with switching out Co2 and LN2 tanks

Physical Requirements

• Requires training in blood borne pathogen safety measures; new hires will be given the option of Hepatitis B vaccination
• Requires standing, walking, pushing, kneeling, twisting and reaching
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals 
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time
• Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements