Sr. Manager, Engineering and Maintenance

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 Sr. Manager of Engineering & Maintenance (E&M) leads a team of Process Engineers, Maintenance personnel and Equipment Coordinators to support all aspects of secondary packaging for parenteral pharmaceutical products. This position is part of a cell-based building management structure, complimented by peer leaders from Operations, Quality, and Technical Services departments. The incumbent will be responsible for leading a department with foundational expectations centered on safety, quality, execution, collaboration, and process improvement to support cell operational metrics and overall plant goals & objectives. The position reports to the Associate Director Engineering & Maintenance Operations.

The 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

Required qualifications:

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

Physical / safety requirements:

Ability to stand or sit for extended periods of time

Ability to utilize required personal protective equipment (PPE)

Dexterity and physical condition to perform some level of repetitive motion tasks

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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