The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root ...
The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root ...
Surgery Assistant
Greenwood, IN · On-site
Knowledge of patient care and aseptic technique preferred OrthoIndy is an Equal Opportunity Employer
Surgery Assistant
Greenwood, IN · On-site
Knowledge of patient care and aseptic technique preferred OrthoIndy is an Equal Opportunity Employer
Pharmaceutical Manufacturing Supervisor, (2nd Shift)
Bloomington, IN · On-site
$56K - $76K/yr
The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in ...
Pharmaceutical Manufacturing Supervisor, (2nd Shift)
Bloomington, IN · On-site
$56K - $76K/yr
The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in ...
Pharmaceutical Manufacturing Supervisor, (2nd Shift)
Bloomington, IN · On-site
$56K - $76K/yr
The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in ...
Pharmaceutical Manufacturing Supervisor, (2nd Shift)
Bloomington, IN · On-site
$56K - $76K/yr
The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in ...
Maintenance Supervisor - Day Shift
Richmond, IN · On-site
$80K - $95K/yr
This is an excellent opportunity to join a growing team at a cutting-edge facility installing five new servo-driven aseptic lines. We're seeking hands-on supervisors who excel in fast-paced, highly ...
Quick apply
Maintenance Supervisor - Day Shift
Richmond, IN · On-site
$80K - $95K/yr
This is an excellent opportunity to join a growing team at a cutting-edge facility installing five new servo-driven aseptic lines. We're seeking hands-on supervisors who excel in fast-paced, highly ...
Maintenance Supervisor - night shift
$85K - $95K/yr
This is a great opportunity to join a growing team at a cutting-edge facility installing five new servo-driven aseptic lines. We're looking for hands-on supervisors who thrive in a fast-paced, highly ...
Quick apply
Maintenance Supervisor - night shift
$85K - $95K/yr
This is a great opportunity to join a growing team at a cutting-edge facility installing five new servo-driven aseptic lines. We're looking for hands-on supervisors who thrive in a fast-paced, highly ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Quick apply
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Applies aseptic principles while scrubbing and assisting surgeons, maintaining sterile technique and correcting breaks in sterility. * Prepares and maintains the sterile field, performs skin preps ...
Applies aseptic principles while scrubbing and assisting surgeons, maintaining sterile technique and correcting breaks in sterility. * Prepares and maintains the sterile field, performs skin preps ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Perform aseptic manipulations within Grade A isolators. * Perform cleaning and sanitization, equipment preparation, and aseptic filling duties as needed. * Safely operate production equipment ...
Perform aseptic manipulations within Grade A isolators. * Perform cleaning and sanitization, equipment preparation, and aseptic filling duties as needed. * Safely operate production equipment ...
CardiovVascular Operating Room (CVOR) Registered Nurse RN
Indianapolis, IN · On-site
$65.40/hr
Maintain aseptic techniques and actively monitor situations which could lead to breaches in aseptic technique. * Coordinate the operating room with respect to sterility, cleanliness, availability of ...
CardiovVascular Operating Room (CVOR) Registered Nurse RN
Indianapolis, IN · On-site
$65.40/hr
Maintain aseptic techniques and actively monitor situations which could lead to breaches in aseptic technique. * Coordinate the operating room with respect to sterility, cleanliness, availability of ...
CardiovVascular Operating Room (CVOR) Registered Nurse RN
Indianapolis, IN · On-site
$65.40/hr
Maintain aseptic techniques and actively monitor situations which could lead to breaches in aseptic technique. * Coordinate the operating room with respect to sterility, cleanliness, availability of ...
CardiovVascular Operating Room (CVOR) Registered Nurse RN
Indianapolis, IN · On-site
$65.40/hr
Maintain aseptic techniques and actively monitor situations which could lead to breaches in aseptic technique. * Coordinate the operating room with respect to sterility, cleanliness, availability of ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Applies aseptic principles while scrubbing and assisting surgeons, maintaining sterile technique and correcting breaks in sterility. * Prepares and maintains the sterile field, performs skin preps ...
Applies aseptic principles while scrubbing and assisting surgeons, maintaining sterile technique and correcting breaks in sterility. * Prepares and maintains the sterile field, performs skin preps ...
Surgical Technologist First Assist (SFA), Ambulatory Surgery- Registry, Day
Crown Point, IN · On-site
Demonstrates infection control practices by utilizing proper aseptic technique while dealing with blood/body fluid. * In conjunction with Unit leadership, Charge Nurse and Central Sterile Processing ...
Surgical Technologist First Assist (SFA), Ambulatory Surgery- Registry, Day
Crown Point, IN · On-site
Demonstrates infection control practices by utilizing proper aseptic technique while dealing with blood/body fluid. * In conjunction with Unit leadership, Charge Nurse and Central Sterile Processing ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, and/or within highly regulated industries as well as knowledge and experience in aseptic filling ...
Applies aseptic principles while scrubbing and assisting surgeons, maintaining sterile technique and correcting breaks in sterility. * Prepares and maintains the sterile field, performs skin preps ...
Applies aseptic principles while scrubbing and assisting surgeons, maintaining sterile technique and correcting breaks in sterility. * Prepares and maintains the sterile field, performs skin preps ...
Aseptic information
What is an aseptic?
An aseptic job involves maintaining a sterile environment to prevent contamination in industries like pharmaceuticals, biotechnology, and food production. Workers follow strict protocols, including gowning, sanitization, and cleanroom procedures, to ensure product safety. Common roles include aseptic technicians, operators, and quality control specialists. These jobs are crucial in producing sterile medications, medical devices, and other products requiring contamination-free conditions.
What are the typical daily responsibilities for someone working in an aseptic environment?
Aseptic technicians are responsible for preparing, filling, and packaging pharmaceutical or biotechnology products in strictly controlled sterile environments. Daily tasks include gowning up using aseptic techniques, operating filling and sealing machines, monitoring cleanroom conditions, and documenting every process step to comply with regulatory standards. You’ll also be part of routine cleaning, equipment set-up, and frequent inspections to avoid contamination. Collaboration with quality assurance teams and production supervisors is common to ensure all procedures meet Good Manufacturing Practice (GMP) requirements. This role is ideal for individuals who thrive in detail-oriented, process-driven settings and value contributing to patient safety.
What are the key skills and qualifications needed to thrive in the aseptic position, and why are they important?
To thrive as an Aseptic technician, you need a strong understanding of sterile technique, careful attention to cleanliness, and familiarity with Good Manufacturing Practices (GMP), often supported by a high school diploma or associate degree in a science-related field. Experience with autoclaves, laminar flow hoods, and sterile filling equipment, along with training in aseptic gowning and contamination control, is typically required. Strong teamwork, attention to detail, and clear communication help ensure precision and safe operations in highly regulated environments. These skills are crucial for maintaining product safety, complying with industry standards, and supporting smooth production workflows.
What are popular job titles related to Aseptic jobs in Indiana? For Aseptic jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Aseptic jobs in Indiana look for? The top searched job categories for Aseptic jobs in Indiana are:
What cities in Indiana are hiring for Aseptic jobs? Cities in Indiana with the most Aseptic job openings:
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Posted 13 days ago
Job description
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 Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy. The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation. It requires managing multiple investigations simultaneously and supporting audits by clearly communicating findings.
Schedule: Friday-Sunday 7:00pm-7:30am
The responsibilities:
Required qualifications:
Physical / safety requirements:
In return, you'll be eligible for[1]:
[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/
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 Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy. The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation. It requires managing multiple investigations simultaneously and supporting audits by clearly communicating findings.
Schedule: Friday-Sunday 7:00pm-7:30am
The responsibilities:
- Lead and execute investigations for deviations, including defining scope, applying structured problem-solving methods, and documenting results in compliance with cGMP standards.
- Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
- Investigate the root cause(s) of the issue and document the investigation results
- Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
- Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness
- Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines
- Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data
- Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency
- Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performance
- Serve as an operations subject matter expert (SME), providing technical guidance on process performance, aseptic practices, and equipment operation
- Draft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations
Required qualifications:
- BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience
- 2+ years technical writing experience, preferably in pharmaceutical industry
- Must have knowledge of GMPs and worldwide regulatory agency guidelines.
- Knowledge of applicable CAPA procedures, specifications, regulations and standards
- Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
- Goal-setting, prioritize, organization, attention to detail, and time management skills
- Critical & creative thinking and problem-solving skills
- Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
- Strong oral and written communication skills
- Ability to demonstrate strong leadership skills
- Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
- Ability to utilize enterprise software systems (Veeva)
Physical / safety requirements:
- Duties will require overtime work, including nights and weekends on occasion
- Ability to gown in C/D gowning area
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/