Shutdown Helper Jobs in Indiana (NOW HIRING)

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 Maintenance Planning & Materials Manager is responsible for leading the site's Maintenance Work Management function, including maintenance planning and scheduling, CMMS governance, MRO storeroom operations, shutdown planning, and maintenance performance management. This position ensures maintenance activities are effectively planned, prioritized, resourced, scheduled, and executed to maximize equipment reliability, support production objectives, maintain GMP compliance, and optimize maintenance costs. The role serves as the process owner for the site's maintenance work management program and provides leadership to the Maintenance Planning, CMMS Administration, and MRO teams.

The Responsibilities:

Maintenance Work Management & Governance
Own the site's preventative maintenance work management process, including planning, scheduling, prioritization, execution tracking, and continuous improvement.
Lead maintenance scheduling meetings and coordinate priorities across Maintenance, Operations, Engineering, Production, Quality, and Supply Chain.
Establish governance for maintenance planning and scheduling processes.
Develop and report KPIs including PM compliance, schedule compliance, backlog, emergency work, wrench time, labor utilization, and planning effectiveness.
Ensure CMMS data integrity, asset hierarchy governance, PM optimization, and master data management.
Provide strategic maintenance performance updates to site leadership.

Maintenance Planning & Scheduling
Ensure preventive maintenance work is planned, scheduled, and completed on time.
Coordinate maintenance schedules with Operations.
Support planning for capital projects requiring maintenance resources.

Shutdown Planning
Own planning and coordination of planned plant shutdowns.
Develop integrated shutdown schedules.
Coordinate contractors, vendors, Engineering, Operations, Utilities, and Maintenance.
Conduct shutdown readiness reviews and post-shutdown lessons learned.

CMMS Administration
Provide governance of the CMMS.
Maintain PM library and asset hierarchy.
Oversee system upgrades, reporting, and KPI dashboards.
Ensure GMP-compliant maintenance documentation.

MRO Inventory & Storeroom
Lead MRO storeroom operations and inventory strategy.
Optimize inventory levels and cycle counting.
Coordinate purchasing with Supply Chain.
Establish standardized kitting processes.

Required Qualifications:
Bachelor's degree in Engineering, Industrial Technology, Maintenance Management, Supply Chain, Business, or 5+ years of relevant experience.
7+ years of maintenance planning, reliability, or maintenance experience.
Experience in pharmaceutical or GMP manufacturing preferred.
Experience with CMMS systems.
Experience managing maintenance planning and scheduling, shutdown planning, MRO inventory, contractor coordination, and maintenance performance metrics.
Strong understanding of preventive, predictive, and reliability-centered maintenance principles.
Working knowledge of FDA regulations, cGMP requirements, and maintenance documentation practices.
Excellent communication, project management, and cross-functional collaboration skills.

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.

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