Automation Director

4 weeks ago

Petersburg, United States BioSpace, Inc. Full time
About BioSpace, Inc.

BioSpace, Inc. is a leading organization in the pharmaceutical industry, dedicated to reducing chronic generic drug shortages and related high prices in the United States. Established in 2018 by health systems and philanthropies, the organization has grown to include over 55 health systems, representing over 1,500 hospitals and over 30 percent of all U.S. hospital beds. BioSpace, Inc. has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.

Job Description

The Associate Director of Automation and MES is a critical role in the development and implementation of the Automation strategy and oversees a site-based team accountable for the development, implementation, and operational compliance of the BioSpace, Inc. Petersburg process automation philosophy and associated industrial control systems (ICS) including facility, utility, and manufacturing processes, as well as supporting infrastructures.

Key Responsibilities
  • Develop the automation strategy for the site.
  • Lead the Automation Engineering function supporting mission critical Automation Systems in the manufacturing of commercial and clinical products.
  • Accountable for the delivery of all aspects of plant execution/operations systems to support site commissioning, validation, and on-going safety, compliance, and quality manufacturing.
  • Lead and manage the group of automation engineers and represent the Automation Engineering function to other partner groups such as IT, Quality, Validation; Manufacturing, Engineering & Technical Services, ensuring the quality of work and appropriate resources are in place to support ongoing initiatives, operations and projects requiring Automation Engineering Support.
  • Support Manufacturing and Operations by providing strategic direction and tactical support. Troubleshoot day-to-day issues, assigning personnel as necessary to provide comprehensive solutions.
  • Set and drive strategic priorities for the holistic systems technology landscape for the site, including but not limited to oversight of new plants/ facilities, changes to plant execution/operations systems, automation engineering systems, develop and maintain validation lifecycle strategy etc.
  • Responsible to implement, validate, maintain, and govern S95/S88 Standards, Libraries, Interfaces & Systems.
  • Accountable to develop and manage the Leads along with a high performing team to deliver on above responsibilities. Create and sustain a culture of innovation, quality, compliance, accountability, employee engagement, collaboration, diversity, and inclusion.
  • Responsible for inspection/audit readiness (internal and external) in relation to the Automation systems. Also accountable for adherence to cybersecurity corporate requirements, all engineering aspects of data integrity, and provide leadership support for alarm management.
  • Mentor, coach, train and evaluate a team of automation engineers.
  • Implement automation policies and related procedures based on regulations and industry standards.
  • Provide oversight in the authoring and review of SOPs and system support.
  • Analyze operational process problems and recommend appropriate corrective and preventative actions.
  • Participate in the site wide teams to provide cybersecurity alignment and direction.
  • Effectively interact and collaborate with cross-functional departments and vendors to drive automation deliverables.
  • Establish and maintain continuous improvement projects.
  • Participate in regulatory inspections (e.g. FDA, DEA) as a Subject Matter Expert (SME).
Requirements
  • A minimum of a bachelor's degree or similar technical degree is required.
  • 10+ year's progressive experience in automation or related role in the pharmaceutical industry.
  • 5+ years of subject matter expertise with automation execution.
  • Experience with writing software test plans, user requirements, and system design documents.
  • Strong knowledge of programming and troubleshooting Rockwell or Siemens PLCs and Rockwell or Siemens FTView, GE iFix, and/or Wonderware System Platform HMIs.
  • Strong knowledge of Computerized Systems, Compliance regulations and standards.
  • Assist and provide resources in various stages of the engineering project lifecycle from conceptual design, detailed design, specification, implementation, commissioning, qualification, trouble-shooting and continuous improvement of automation and instrumentation for the sterile injectable industry.
  • Collaborate with functional and discipline heads and leads to develop solutions to issues that are immediately impacting business needs. Collaborates effectively with Operations, Quality, Regulatory, Process Development, Supply Chain, and other key groups involved in GMP manufacturing.
  • Demonstrates strong leadership, motivation, teambuilding, communication, and advanced coaching skills that instill a strong sense of mission in a team environment across all levels of organization.
  • Demonstrates excellent planning and organizational skills, with the ability to balance production and maintenance needs.
  • Excellent project management and time management capabilities; with the ability to partner and influence across a matrixed environment. Excellent communication skills; verbal & written.
  • Forecasts and adheres to departmental budget, and responsibly manages cost center resources.
Preferred Qualifications
  • Knowledge of Database/Historian (SQL, AVEVA PI).
  • Knowledge of Vmware and virtualization.
  • Basic networking knowledge.
  • Knowledge of systems such as Allen Bradley PLC platforms, Johnson Controls, Amega or DeltaV, SCADA systems, PI Historian, Siemens PLC S7, iFix, iHistorian, Industrial Ethernet networks, Profibus and AS-I networks.
  • Knowledge and understanding of Data Integrity and how it applies to the BioTech Industry with specific focus on guidelines from the FDA.
  • Exposure to batch and continuous processes found in the pharmaceutical and Biotech Industries is preferred.
  • Experience with S88 and ASTM 2500 principles would be an advantage.
  • Exceptional organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities.
  • Experience with regulatory inspections.
  • Demonstrated management and delivery of large capital projects.
  • Subject matter expertise with Computerized Systems Validation (CSV).
  • Previous experience/best practices implementing and using continuous improvement/lean tools such as; Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.

  • Associate Director Automation

    2 months ago

    Petersburg, United States Civica Rx Full time

    About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...

  • Associate Director Automation

    2 weeks ago

    Petersburg, VA, United States Civica Rx Full time

    Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization. ...

  • Accounting Manager

    3 weeks ago

    Petersburg, United States District 19 Community Service Board Full time

    District 19 Community Services Board (D19CSB) is seeking a qualified Accounting Manager to work in our Petersburg location. The Accounting Manager is responsible for supervision of general accounting functions to include processing of financial transactions, daily bank deposits, payroll processing, grant accounting for restricted funding and ensuring...

  • Sr. Director Software Engineering

    3 weeks ago

    PETERSBURG, United States Capital One Careers Full time

    Center 1 (19052), United States of America, McLean, VirginiaSr. Director Software EngineeringDo you want to work for a tech company that writes its own code, develops its own software, and builds its own products? Do you enjoy solving complex challenges with open source technologies in a fast-paced, collaborative, and creative environment? We experiment and...

  • Director, Software Engineering

    3 weeks ago

    St Petersburg, United States Kobie Marketing Full time

    Why you will love working for a National Top Workplace We are a global leader in loyalty marketing. We work with some of the most well-known brands in the world to deliver market-leading, end-to-end loyalty solutions to enable customer experiences. With a strategy-led, technology-enabled approach, we are consistently named an industry leader by Forrester....

  • Director, Software Engineering

    3 weeks ago

    St Petersburg, United States Kobie Full time

    Why you will love working for a National Top WorkplaceWe are a global leader in loyalty marketing. We work with some of the most well-known brands in the world to deliver market-leading, end-to-end loyalty solutions to enable customer experiences. With a strategy-led, technology-enabled approach, we are consistently named an industry leader by Forrester....

  • Director, Software Engineering

    3 weeks ago

    St Petersburg, United States Kobie Full time

    Why you will love working for a National Top WorkplaceWe are a global leader in loyalty marketing. We work with some of the most well-known brands in the world to deliver market-leading, end-to-end loyalty solutions to enable customer experiences. With a strategy-led, technology-enabled approach, we are consistently named an industry leader by Forrester....

  • Director, Software Engineering

    2 weeks ago

    Saint Petersburg, United States Kobie Full time

    Job DescriptionJob DescriptionWhy you will love working for a National Top WorkplaceWe are a global leader in loyalty marketing. We work with some of the most well-known brands in the world to deliver market-leading, end-to-end loyalty solutions to enable customer experiences. With a strategy-led, technology-enabled approach, we are consistently named an...

  • Revenue Cycle Director

    4 weeks ago

    Saint Petersburg, FL, United States Florida Orthopaedic Institute Full time

    As a key member of the Florida Orthopaedic Institute team, the Revenue Cycle Manager plays a vital role in ensuring the smooth operation of the department. This position is responsible for defining and monitoring key statistical indicators, providing guidance and leadership to staff, and ensuring that daily functions are completed promptly to produce the...

  • Library Assistant

    3 months ago

    St Petersburg, United States Stetson University Full time

    Job Description The Library Assistant position supports Stetson University by providing a friendly library user experience and keeping our resources neat and up to date. Serving as a member of the Law Library Team, the Library Assistant will work regular hours at the circulation, maintain library resources, assist with campus mail, and assist with the...

  • Associate Director, IT Security

    4 weeks ago

    St. Petersburg, United States Raymond James Financial Services Full time

    Job Summary:This role is part of the Technology Risk and Assurance division at Raymond James, where you will lead the security assurance program. The program focuses on penetration testing and other security assessments to inform the firm's security posture. You will be responsible for vendor interactions, including overseeing security assessments and...

  • Process Engineer, Biologics

    4 weeks ago

    Petersburg, United States Civica Rx Full time

    About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...

  • Senior Software Engineering Manager

    4 weeks ago

    Saint Petersburg, FL, United States Kobie Full time

    We are a global leader in loyalty marketing, delivering market-leading, end-to-end loyalty solutions to enable customer experiences. Our strategy-led, technology-enabled approach has consistently earned us industry leadership recognition by Forrester.The Director of Software Engineering manages multiple development squads within the Software Engineering...

  • Senior Software Engineer, DevOps

    2 weeks ago

    PETERSBURG, United States Capital One Careers Full time

    West Creek 6 (12076), United States of America, Richmond, VirginiaSenior Software Engineer, DevOps (Enterprise Platforms Technology)Capital One is seeking talented thinkers and skilled engineers who can envision the next-generation software innovations that will deliver a rich, engaging and unmatched customer experience. In this role, the Cloud Enablement...

  • Office Manager

    3 weeks ago

    St Petersburg, United States Evara Health Full time

    Do you want to make a difference in the community? Are you looking to further your career in healthcare? Do you want to be part of a growing organization? Evara Health has been serving the community for 40 years. We are a not-for-profit health care organization with 14+ locations throughout Pinellas County, FL GENERAL DESCRIPTION: Manages the planning and...

  • Office Manager

    3 weeks ago

    St Petersburg, United States Evara Health Full time

    Do you want to make a difference in the community? Are you looking to further your career in healthcare? Do you want to be part of a growing organization? Evara Health has been serving the community for 40 years. We are a not-for-profit health care organization with 14+ locations throughout Pinellas County, FL GENERAL DESCRIPTION: Manages the planning and...

  • Financial Controller

    1 week ago

    St Petersburg, United States Lantmännen Unibake USA Full time

    Have an appetite for more?Join a leading global bakery group powered by ambitious people who are truly passionate about delivering the best in everything they do. With business in mind and people at heart we always work together to influence our road ahead. We want you to be part of our growth journey and of a great, global family.An exciting opportunity has...

  • Financial Controller

    5 days ago

    saint petersburg, United States Lantmännen Unibake USA Full time

    Have an appetite for more?Join a leading global bakery group powered by ambitious people who are truly passionate about delivering the best in everything they do. With business in mind and people at heart we always work together to influence our road ahead. We want you to be part of our growth journey and of a great, global family.An exciting opportunity has...

  • Financial Controller

    1 week ago

    saint petersburg, United States Lantmännen Unibake USA Full time

    Have an appetite for more?Join a leading global bakery group powered by ambitious people who are truly passionate about delivering the best in everything they do. With business in mind and people at heart we always work together to influence our road ahead. We want you to be part of our growth journey and of a great, global family.An exciting opportunity has...