Sr. IT Analyst, OT

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.

 

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This role:

 

Sr. IT Analyst, OT role is responsible for providing technical support and maintenance for IT systems and equipment used in the manufacturing environment, ensuring optimal performance and reliability to support production processes at our Bloomington, Indiana facility.

 

Primarily, this role is responsible for the ongoing, 24x7, IT OT 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 handful of independent contractors as necessary to meet the objectives and operational reliability of the facility. This individual will also partner directly with the Engineering and OT teams to deliver on their objectives and be the primary contact for those teams into the greater IT organization and its offshore partners.

 

The responsibilities:

 

Plant OT Support and Maintenance

• Respond to on-call support requests and participate in after-hours support as needed.
• Ensure timely communication with stakeholders regarding system status, issues, and resolutions.
• 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.
• Ensure adherence to the organization’s security policies and procedures.
• Collaborate 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.
• Participate in the research, analysis, selection, and implementation of new tools, technologies and/or services.
• Provide training for OT staff on best practices related to IT processes and procedures.

 

Project Management and Execution

• Participate in Project meetings and contribute accordingly to area of expertise
• Assist and support OT capital planning costs as they relate to IT resources and requirements
• Participate in the budget process as needed

 

Plant OT and Manufacturing Technology Partnership

• Develop strong 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 plant and operational OT objectives.

 

 Change Management, Quality Assurance and Control

• Support OT Technology change management processes and procedures in alignment with global change processes
• Advise and support OT on changes, upgrades or improvements to validated systems
• Advise and support OT on requirements as they relate to data integrity

 

Documentation and Reporting

• Document internal processes and procedures related to duties and responsibilities.
• Document all assets and maintain the global CDMB daily.
• Provide regular project updates and reports to management and project teams on status, challenges, and issues

 

Required qualifications

• Knowledge of Manufacturing Operations and Enterprise Management Systems required
• Knowledge of Pharmaceutical Manufacturing a plus.
• 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
• Knowledge of VMware, ESXi and vCenter configuration, administration, and utilization.
• Follows Quality Assurance standards to deliver stable, reliable, and highly available solutions.
• Ability to prioritize projects and tasks with respect to business needs.
• Proven regular participation in successful support activities.
• Ability to manage multiple tasks and projects for multiple requestors.
• Strong interpersonal communication skills; flexibility; responsiveness.
• Ability to work on-call 24x7 as part of a weekly rotation or as plant needs require.
• Other duties as assigned.

 

Experience, Knowledge, Skills

• Progressive Experience with installation and support of Windows OS including Server 2019.
• Design, implementation and support of VMWare vSphere 6.0 and higher.
• Server builds and maintenance following best practices
• Knowledge/experience with Data Center management, maintenance and best practices
• DNS, DHCP, and TCP/IP network protocols and Wireless communications
• Basic firewall principles.
• Extensive exposure to evaluation, selection, adoption and management of new technologies and related infrastructures.
• Strong understanding of/experience with service-based organizational environments.
• Proven participation in successful IT projects, implementation, upgrades and regular support activities.
• Strong customer service focus
• Strong communication, problem solving and interpersonal skills.
• Must be able to schedule and prioritize assignments as needed.
• Form and maintain exceptional vendor relationships
• Experience resolving user helpdesk tickets
• Willingness to work with legacy computer hardware and ability to improvise to keep systems running when needed.
• Experience in maintaining quality documentation required in a 21 CFR Part 11 compliant environment a plus.

 

Job Requirements (Education and Experience):

• Ability to work on-call 24x7 as part of a weekly rotation
• Minimum 5+ years of relevant technical experience.
• Technical certifications preferred from Cisco, Citrix, Microsoft and VMWare

 

Physical / Safety Requirements:

• Frequently required to sit, stand and use hands to perform data entry
• Occasionally required to perform simple grasping, use hands for fine manipulation, and to reach above shoulder level and under desks.
• Need close vision and ability to adjust focus.
• Ability to lift and carry 25 lbs or more.

 

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
• 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 12/31/24

 

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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.

 

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