Simtra BioPharma Solutions
Quality Technician
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 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. The 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 and critical utilities 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 (LIMS). Maintains data integrity and ensures compliance with company standard operating procedures (SOP's) and worldwide regulatory requirements. May be responsible for critical systems testing, microorganism identification, and environmental monitoring duties depending on lab assignment. May be required to recognize non-conformances as well as initiate and author non-conformance reports. Required Qualifications
High school diploma or GED. Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, LIMS etc.) One year work experience in a regulated environment required. 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. Position may require handling laboratory chemicals. 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 25 lbs Must be able to qualify for 20/25 corrected vision and pass color blindness test. Must be able to squat and maneuver under equipment while carrying materials. In Return, You'll Be Eligible For
Day One Benefits Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Spouse Life Insurance Child 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 and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits 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 12/31/25 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. To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy.
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 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. The 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 and critical utilities 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 (LIMS). Maintains data integrity and ensures compliance with company standard operating procedures (SOP's) and worldwide regulatory requirements. May be responsible for critical systems testing, microorganism identification, and environmental monitoring duties depending on lab assignment. May be required to recognize non-conformances as well as initiate and author non-conformance reports. Required Qualifications
High school diploma or GED. Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, LIMS etc.) One year work experience in a regulated environment required. 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. Position may require handling laboratory chemicals. 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 25 lbs Must be able to qualify for 20/25 corrected vision and pass color blindness test. Must be able to squat and maneuver under equipment while carrying materials. In Return, You'll Be Eligible For
Day One Benefits Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance Spouse Life Insurance Child 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 and more Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits 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 12/31/25 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. To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy.