Equipment Coordination Supervisor
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 excellencefulfilling 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 Equipment Coordination Supervisor is a key member of a high-performance team responsible for supporting daily manufacturing operations and equipment in an aseptic sterile environment. This position reports to the Senior Manager Engineering and Maintenance and functions as the supervisor over the equipment coordinators.
Theresponsibilities:
Responsible for implementing and supervising daily activities related to equipment coordination to ensure manufacturing goals and projects are met while maintaining compliance with current Good Manufacturing Practices.
Issue and track all product contact equipment for all GMP production batches as well as for non-GMP batches and testing activities.
Manage inventory for all productcontact equipment including monitoring equipment condition coordinating repairs and initiating procurement of new equipment or spare parts as required.
Maintain accurate equipment lifecycle data and status updates in Microsoft Dynamics 365 ensuring traceability and documentation accuracy.
Serialize passivate and etch all new equipment and enter equipment asset into Microsoft Dynamics 365 software package.
Partner with Technical Services to ensure availability and readiness of equipment for new product introductions process modifications and projectrelated changes.
Review all manufacturing batch records and equipment project plans.
Support documentation and changecontrol activities related to equipment ensuring alignment with internal quality standards and regulatory expectations.
Participate in spare part analysis and inventory development.
Required qualifications:
High school diploma or GED required. Associates degree preferred.
Minimum 2 years of industrial manufacturing maintenance or engineering experience required.
Minimum 1 year of leadership experience required.
Computer proficiency in Microsoft Word Excel and Outlook and the ability to use enterprise software (examples include: JDE BPLM Dynamics Trackwise etc.)
Physical / safety requirements:
Must be able to lift push/pull and carry up to 50 pounds
May be required to stand for over 4 hours per day
Must be able to lift 20 pounds overhead
Must be able to wear personal protective equipment including respirator
Must be able to qualify for entry into Grade C Manufacturing area.
Duties may require overtime work including nights and weekends
In return youll be eligible for1:
- 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 Simtras approach to data privacy please review the Simtra Recruitment Platform Global Privacy Policy: Experience:
Manager
Key Skills
- Parts Inventory
- Cost Reduction
- Equipment Maintenance
- Maintenance Procedures
- personal protective
- API
- CAD
- SolidWorks
- Process Engineering
- PLC
- Preventive Maintenance
- Process Equipment
- Maintenance Activities
- Technical Support
- Air Compressors
About Company
THIS IS WHERE IT ALL BEGAN Did you know that Baxter is the first commercial manufacturer of prepared IV solutions? It all started in 1931 in Iowa when Dr. Ralph Falk and Dr. Donald Baxter launched the Don Baxter Intravenous Products Company. Hillrom’s roots go back to when Bill Hille ... View more
