Aseptic Equipment Lead (2nd Shift)
Not Disclosed•Full-TimeOn-site
location_onTent Area D, Paynetown Road, Monroe County, Indiana, United States
About Simtra BioPharma Solutions
Simtra is a world-class Contract Development and Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. With facilities in Bloomington, Indiana, and Halle/Westfalen, Germany, we deliver a wide range of systems including pre-filled syringes, liquid and lyophilized vials, diluents, and sterile crystallization solutions.
Our product portfolio spans biologics, small molecules, cytotoxics, highly potent compounds, and vaccines—all directly injected into patients worldwide. This critical mission drives a strong emphasis on quality and continuous improvement. While our primary focus is cGMP manufacturing, we also provide comprehensive support services including formulation, development, lyophilization optimization, global regulatory support, and secondary packaging. Our teams are dedicated to helping clients scale, innovate, and bring life-changing medicines to patients globally.
Why Join Team Simtra?
We are driven by four core principles that define our culture:
- Make it HAPPEN: We bring a growth mindset to every opportunity, developing new skillsets and exceeding expectations for our customers and ourselves.
- Make it TOGETHER: We work as one unit, respecting every voice and leveraging our unique strengths across teams to solve problems in innovative ways.
- Make it RIGHT: We hold ourselves to a high standard of excellence, fulfilling our commitments to our customers, their patients, and our team members.
- Make it COUNT: We take pride in our day-to-day work, understanding the impact we make by taking on challenges big and small to improve patient health.
About the Role
As an Aseptic Equipment Lead (AEL), you will be at the heart of our sterile manufacturing operations. You will own the setup, performance, and optimization of a key aseptic filling line during your shift, making a direct impact on production success, product quality, and team efficiency. Working closely with Engineering, Maintenance, and Filling Operators, you will serve as the go-to expert for the equipment in your area and a driving force behind continuous improvement.
You will work in a fast-paced, hands-on sterile manufacturing environment with direct interaction with complex automated equipment. A significant portion of your time will be spent within Grade A–D cleanroom spaces, supporting the critical production of high-quality sterile products. This role requires a strong mechanical aptitude and the ability to troubleshoot in an equipment-focused environment.
Equal Opportunity
Simtra is proud to be an equal opportunity employer. We evaluate 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/
Work location
Work model: On-site
Tent Area D, Paynetown Road, Monroe County, Indiana, United States
Indiana
Key Responsibilities
- check_circleLead troubleshooting efforts by investigating complex issues and implementing long-term solutions
- check_circleMonitor and evaluate line performance to support Out of Control Limit Reports and ensure inspection readiness
- check_circleAnalyze trends to reduce downtime, improve operator efficiency, and boost product yield
- check_circleStandardize and train operators on equipment setup and basic troubleshooting procedures
- check_circlePartner with engineers and operational excellence teams to champion safety and quality improvements
- check_circleMaintain Grade A/B aseptic gowning certification and complete operator qualification requirements
- check_circleServe as subject-matter expert for assigned aseptic filling lines and supporting systems
Requirements
- verifiedHigh school diploma or GED
- verifiedAt least 3 years of manufacturing experience
- verifiedProficiency in Microsoft Word, Excel, and Outlook
- verifiedStrong mechanical aptitude
- verifiedAbility to troubleshoot in a hands-on, equipment-focused environment
- verifiedMaintain Grade A/B aseptic gowning certification
- verifiedComplete operator qualification/media fill requirements
Benefits & Perks
check_circleMedical, dental, and vision coveragecheck_circleFlexible Spending Accountscheck_circleLife and AD&D insurance including spouse and child coveragecheck_circle401(k) Retirement Savings Plan with Company Matchcheck_circlePaid Holidays, Paid Time Off, and Paid Parental Leavecheck_circleAdoption Reimbursement Programcheck_circleEducation Assistance Programcheck_circleEmployee Assistance Programcheck_circleCommunity and Volunteer Service Programcheck_circleEmployee Ownership Plan
Similar Job Opportunities
Skills, education and keywords
Skills: Microsoft Word, Excel, Outlook, Veeva, D365, Blue Mountain, CGMP, Aseptic Gowning, Media Fill, Lyophilization.
Education: High school diploma or GED required.
Frequently asked questions about Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions
What does a Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions do?expand_more
A Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions is responsible for the following: Lead troubleshooting efforts by investigating complex issues and implementing long-term solutions; Monitor and evaluate line performance to support Out of Control Limit Reports and ensure inspection readiness; Analyze trends to reduce downtime, improve operator efficiency, and boost product yield; and Standardize and train operators on equipment setup and basic troubleshooting procedures.
What are the requirements for this Aseptic Equipment Lead (2nd Shift) role?expand_more
Simtra BioPharma Solutions is looking for candidates who meet the following requirements: High school diploma or GED; At least 3 years of manufacturing experience; Proficiency in Microsoft Word, Excel, and Outlook; Strong mechanical aptitude; Ability to troubleshoot in a hands-on, equipment-focused environment; and Maintain Grade A/B aseptic gowning certification.
Where is the Aseptic Equipment Lead (2nd Shift) role at Simtra BioPharma Solutions located?expand_more
Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions is based in Tent Area D, Paynetown Road, Monroe County, Indiana, United States. This is a on-site role.
Is this Aseptic Equipment Lead (2nd Shift) job remote, hybrid, or on-site?expand_more
Simtra BioPharma Solutions has listed this Aseptic Equipment Lead (2nd Shift) role as on-site.
How much experience is required for this Aseptic Equipment Lead (2nd Shift) role?expand_more
Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions typically requires 3+ years of relevant experience at the lead level.
What skills do you need for the Aseptic Equipment Lead (2nd Shift) role at Simtra BioPharma Solutions?expand_more
Key skills for Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions include Microsoft Word; Excel; Outlook; Veeva; D365; Blue Mountain; CGMP; and Aseptic Gowning.
What education is required for Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions?expand_more
Educational requirements for this role: High school diploma or GED required.
What category does the Aseptic Equipment Lead (2nd Shift) role belong to?expand_more
Aseptic Equipment Lead (2nd Shift) at Simtra BioPharma Solutions is part of the manufacturing job category on Recrutus.
About Simtra BioPharma Solutions
Simtra BioPharma Solutions operates within the pharmaceutical manufacturing industry, providing contract development and manufacturing organization (CDMO) services from its headquarters in Parsippany, New Jersey. With more than 65 years of experience in sterile injectable production, the company specializes in cGMP sterile fill/finish operations. As an independently owned entity and a tradename of Baxter Oncology GmbH and Simtra US LLC, it delivers technical expertise alongside quality service to support client needs.
The organization partners with pharmaceutical and biotech companies facing specific challenges such as complex formulation requirements, clinical supply constraints, demand surges caused by market fluctuations, or risk mitigation strategies. The focus remains on delivering tailored and versatile solutions designed to assist clients in advancing their products to market. By addressing these operational hurdles, the company aims to facilitate the delivery of medicines to patients who require them.
Browse more roles: All Simtra BioPharma Solutions jobs, manufacturing jobs on Recrutus.