Director, 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:

Responsible for the strategic planning for the department. Provides leadership in the development of new ideas, products, processes and techniques. Frequently manages an organization and a budget in excess of $50 million dollars. This role also provides leadership in the development of a preventative maintenance program, robust maintenance strategies and processing engineering strategies that align with production and facility goals. Directs through management team the completion of complex projects or programs within boundaries of quality, time and budget. Based on significant technical expertise, reviews and approves complex design concepts of technical staff. Provides technical direction to staff. Fosters an environment of creativity and innovation in completing divisional and cross-functional/business unit responsibilities.

The responsibilities:

• Provides strategic planning leadership by setting strategies and priorities based upon anticipation and application of industry trends and emerging technologies.
• Create and communicate global vision of the organizations contribution to the business unit/division goals, insuring industry leadership.
• Maximize the effectiveness of internal and external resources (business unit and cross-business unit) to meet business objectives.
• Develop and implement preventive maintenance programs to ensure equipment reliability, minimize downtime, and optimize production efficiency.
• Lead a team responsible for troubleshooting, repairing, and maintaining complex machinery, HVAC systems, utilities, and facilities infrastructure.
• Direct the development and implementation of new product/process requiring new technologies starting from Project Proposal through Post-launch Quality Assessment.
• Using broad knowledge and experience in cross-functional activities, coordinate and direct activities of teams and individual contributors to ensure market dominance in appropriate product lines.
• Create and maintain an environment where team members experience personal and professional growth and become a more self-directed team.
• Responsible for Final Approval on product/process documentation.
• Review and approves proposals to determine if benefits derived and possible applications justify expenditures. Presents proposal to senior management for consideration and allocation of funds. Responsible for preparation of project cost estimates up to multi-million dollar range. Directs all project expenditures and cost tracking.
• Provide strategic planning leadership to ensure adequate resources are available to complete all business unit and division responsibility.
• Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Required qualifications:

• BS in relevant engineering discipline, with advanced technical degree or equivalent experience.
• 12 or more years of relevant technical experience.
• Several years of technical management experience including cross-functional teams, resource and budget management and strategic development experience

Additional requirement(s):

• Must possess strong knowledge of engineering disciplines (e.g. fluid flow, thermodynamics, heat transfer, static's and dynamics, engineering materials) and solid knowledge of related disciplines.
• Ability to establish long-range business plans which anticipate global trends, technical, economic and socio-political conditions.
• Demonstrate understanding of business drivers, customer needs and global dynamics to create viable strategic plans.
• Proven track record of management/leadership effectiveness.
• Must possess strong ability to negotiate and maximize effectiveness of resources and influence others internally and externally.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

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
  • 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
• Additional Benefits
  • 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 12/31/25

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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