Simtra BioPharma Solutions · 1 month ago
Sr. Manager Engineering and Maintenance
Bloomington, Indiana, United States
Full-time
Onsite
Senior Level
7+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies. The Sr. Manager of Engineering & Maintenance leads a team to support secondary packaging for parenteral pharmaceutical products, focusing on safety, quality, and continuous improvement.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Responsible for maintaining departmental headcount and all associated administrative and planning functions, including interviewing candidates, hiring, onboarding & training, personnel development, performance management, scheduling, directing day-to-day activities and project oversight
Responsible for equipment performance, preventive/scheduled maintenance, emergency maintenance, vendor scheduling, and project management - including timely repair and sourcing of critical parts or components
Responsible for coordinating all activities and/or repairs related to facilities maintenance for building
Responsible for Total Productive Maintenance (TPM) program focused on identifying overall equipment efficiencies to enhance production processes and quality
Supports identification and procurement activities related to new process equipment. Includes generation of user specification documents, installation, commissioning, and qualification activities Provides oversight and management for process engineers regarding project ownership, including collaboration with CAPEX project engineers, and project timelines
Works closely with peer cell leaders towards common goals to track and report department specific metrics within the cell
Responsible for identification and implementation of corrective actions to improve performance and compliance
Complies with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), and rigorous quality standards and holds team to same expectation
Maintains a clean and safe work area using 6S (6 Sigma) principles
Ensures team is compliant with safe work practices and electrical requirements, including LOTO (Lock Out, Tag Out), safe work permits, and all Personal Protective Equipment (PPE) required to safely complete assigned work
Lead and/or support a variety of complex issues & projects as applicable
Apply technical expertise and troubleshooting philosophies with a variety of technologies including: syringe & vial aseptic filling machines and related process equipment, autoclaves, lyophilizers, terminal sterilizers, isolator systems, Human Machine Interface (HMI), PLCs, clean utilities, HVAC, SCADA systems and electrical control systems
Ability to troubleshoot complex automated machinery and manual/mechanical based equipment or applications
Fully accountable for the performance of self and team
Qualification
Required
BS degree in Engineering or a related field of study
7+ years of manufacturing experience
Prior experience and familiarity working in a cGMP environment
3+ years of leadership / supervisory experience
Demonstrated examples of successful project execution
Track record in technical management of process equipment in a manufacturing environment, with experience in electrical, mechanical, and automated applications
Able to analyze and solve complex problems
Knowledge of GMPs, FDA guidelines, purchasing practices and process validation
Team building experience in guiding multi-disciplinary teams on medium complexity issues, while providing technical direction to individual engineering disciplines
Ability to translate business goals into action plans
Understanding and proficiency in reliability-centered maintenance principles and practice
Results-oriented mindset, capable of independent thought, adaptable, ready to respond and react to real-time situations with realistic and viable technical, organizational, and administrative solutions
Advanced proficiency in Microsoft Office Suite
Ability to utilize enterprise software applications: Maximo, Veeva, Microsoft Dynamics, Blue Mountain
Ability to communicate effectively and professionally
Ability to write and review technical documents
Demonstrated efficient written and verbal communication skills
Minimal travel required (less than 10%), including potentially supporting equipment FAT
Ability to apply and utilize Root Cause Analysis (RCA) tools
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
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase