For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement.  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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.


Your role at Simtra BioPharma Solutions:

This IT leadership role is responsible for the overall IT and Technology operations at our Bloomington, Indiana facility. This position currently reports to the CIO of Simtra and has a dual reporting relationship with the Plant Manager. This role sits on the Senior Leadership Team of the facility and plays a critical role in aligning the local facility’s plans to the overall corporate technology strategy and plan.

Primarily, this role is responsible for the ongoing, 24x7, IT operations of the facility and the applications support of any systems local to the facility. This includes, but is not limited to computer systems, IoT devices, networks, software applications, printers, scan guns, and hardware devices required to support business operations.

This individual will manage a team of 5 or more direct personnel and a handful of independent contractors necessary to meet the objectives and operational reliability of the facility.

What you'll do:

IT Team Responsibilities Include:

  1. Plant IT Operations, Support, & Maintenance - Local
    • Ensure the plant is supported on a 24x7 basis
    • Ensure that all issues are rectified within the designated SLAs on a 24x7 basis to ensure the continuous operation of the facility
    • Support the contracting, maintenance, management and ongoing operation of any and all local applications that are not fully supported by the enterprise support organization or methods.
  2. Plant & Software IT Operations, Support, & Maintenance - Global
    • Ensure the support team is properly servicing tickets with the designated SLAs to support our follow-the-sun model that enables our personnel to support our global facilities and enterprise IT needs
  3. Project Management and Execution - Local:
    • Develop and execute project plans, ensuring timely and successful delivery of technical projects focused on the local facility.
    • Coordinate meetings, set agendas, and identify action items with Third Party Vendors and Internal teams.
    • Execute short- and long-term work plans, supporting delegation of work.
    • Act as a liaison between various stakeholders, ensuring clear and effective communication throughout the project lifecycle.
  4. Project Management and Execution - Enterprise:
    • Act as the primary communications method to the broader plant leadership team and organization on any enterprise IT changes and their impact
    • Lead the execution and implementation of enterprise IT changes
    • Become a change management champion to lead the transformation of the facility and to drive continuous improvement opportunities inside and outside of IT.
  5. Local OT and Manufacturing Technology Partnership
    • Develop tight working relationship with the Operational Technology organization to aid in the implementation of their technologies, controls, and production equipment to support the growth and expansion of the company
    • Provide key expertise and leadership in the areas of servers, operating systems, virtual servers, storage, cloud servers, network, security, low voltage wiring, desktop os, desktop hardware, printers, scan guns, label printers, and IT security in the support of any and all plant and operational OT objectives.
  6. Change Management, Quality Assurance and Control:
    • Establish and manage local technology change management processes and procedures
    • Work with local CSV/CSA resources on any changes or improvements to validated systems
  7. Documentation and Reporting:
    • Document internal processes and procedures related to duties and responsibilities.
    • Document all assets and contracts and maintain the global CDMB on a daily basis.
    • Provide regular project updates and reports to management and project teams on performance, challenges, and issues

Individual Responsibilities Include:

Team Leadership and Motivation:

  • Supervise and lead a team of IT professionals, including hiring, training, and performance evaluation.
  • Develop departmental objectives/ensure they align with both the business and IT strategies and objectives.
  • Lead and motivate project teams, fostering a collaborative and high-performance work environment.
  • Partner with internal and external partners to communicate project status, activities, and achievements.

 

Senior Leadership Team and Technical Leadership:

  • Participate in Senior Leadership Team meetings and contribute accordingly to your area of expertise
  • Oversee the maintenance, configuration, and security of computer systems, servers, networks, and other IT infrastructure components at the plant.
  • Ensure adherence to the organization’s security policies and procedures.
  • Collaborating with external vendors and service providers to ensure the delivery of quality IT services and support.
  • Interact regularly with internal customers to understand their business and to anticipate needed IT solutions.
  • Review team, group and/or service deliverables to ensure quality (design walk-through, test results, etc.) and adherence to the processes, standards, and regulatory requirements.
  • Participate in the budget process and monitor the budget as appropriate.  Assist the business with IT capital and operating expense investment requirements.
  • Participate in the research, analysis, selection, and implementation of new tools, technologies and/or services.
  • Develop, gather, and measure relevant productivity metrics.
  • Manage or participate in projects, customer changes, and plant expansions as required.
  • Participate in Client and Regulatory audits as required.

 

What you’ll bring:

  • A bachelor's degree in computer science, information technology, or a related field preferred or relevant work experience
  • Minimum of 12 years of systems experience including 5+ years of leadership and management experience required.
  • Expert knowledge of IT best practices, policies, and regulations
  • Excellent customer service, interpersonal communication, and public-speaking skills, including active listening.
  • Demonstrated ability to lead and manage a team effectively, including hiring, training, performance evaluation and conflict management.
  • Knowledge of Manufacturing Operations and Enterprise Management Systems required
  • Knowledge of Pharmaceutical Manufacturing a plus.
  • Experience providing executive-level briefings and presentations.
  • Strong problem-solving, critical thinking and decision-making skills
  • Works with limited oversight/comfortably address complex problems in a manufacturing environment regulated by the FDA.
  • Strong knowledge of IT security principles, best practices, and compliance requirements.
  • Strong technical knowledge and proficiency in various IT areas such as network administration, system administration, database management, cybersecurity, cloud computing, and software development.
  • Project Management skills, including organization, planning, time management and prioritization.
  • Proficient with all Microsoft Office applications
  • Basic knowledge of VMware, ESXi and vCenter configuration, administration, and utilization.
  • Demonstrated success of project implementations and customer service performance.

 

 


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Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
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