Our clients are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
About the Role:
You will provide operational and project support for the Utilities Automation infrastructure. You may participate in a rotating after-hour process control support function. We ask that you become familiar with the manufacturing process, utilities generation or operations. Support capital and continues improvement (CI) projects involving EBM, PLC's or distributed Control Systems- with software changes adhering to change control requirements. You will support EBM Siemens Solution, OSI-PI plant historian, reporting tools, Control System network (Cisco communication devices) and others. This role reports to the Associate Engineering Director at our Social Circle, GA
location.
How you will contribute:
Manage and coordinate the EBM Team, initiative and project
Expected to make suggestions on improvements based on supporting data, technical knowledge, engineering principles and current industry practices.
Manage EBM activities for capital project.
Lead the execution of EBM automation activities for operational activities and capital projects by working in teams as the Engineering lead/representative for the EBM automation area
Define project scopes, prepare time or cost estimates, and provide justification for operational initiative and capital budget.
Manage spending of approved operational and capital automation projects funds.
Bring projects to completion within the timeline and budget objectives.
Maintain written Stand Operating Procedures (SOPs) related to project assignments.
Maintain technical support specifications (Design/Functional/System) related to project assignments.
Supervise contractors and junior level engineering personnel on project and operational support activities.
Demonstrate continuous improvement for increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, and technical understanding capability.
Stay current with biopharmaceutical industry best practices and technologies.
Evaluate customer problems or requirements and address those through the system solutions or design.
Design and implement changes to EBM or automation systems while adhering to pharmaceutical validation and change control standards.
Troubleshoot and diagnose control system problems.
Perform event's investigation related to EBM automation system and implement the corrective and preventive action required to address the event.
Perform hardware/software modifications, and system functional specification updates.
Prepare standard operating procedures for all control equipment.
Mentor Automation Engineers - EBM.
Requirements/Qualifications:
Bachelor's degree in Sciences, Technology, Mathematic or Engineering with at least 5+ years, of related automation/controls experience in a GMP pharmaceutical environment is required.
Programming/design "hands-on" experience with EBM, Computer system programming and control system is required:
Experience configuring, troubleshooting and using Windows Operating Systems, Networking, virtualization and Databases for Control System Applications
Experience with data historians (like OSI-PI), MS-SQL and reporting tools are desirable.
Experience supporting of control systems in the Bio- Pharma industry.
1+ year Supervisor/Lead/Management experience running a team
Key Skills, Abilities and Competencies
Must have demonstrated experience implementing automation, control Electronic Batch Record system projects, and supporting operating facility, on a FDA regulated manufacturing environment.
Knowledge of core principles in multiple information Technology and engineering disciplines including manufacturing (i.e. cell culture/fractionation//purification/aseptic filling/packaging/cGMP facility design, electronic batch record).
Display an understanding of theories/practices utilized by other disciplines outside primary area of expertise.
Good communication skills as you will interact with teams and management on recommended course of action.
Must be experienced using Word, Excel, and PowerPoint, MSVisio and MS Project.
Lead Engineering or computer system projects, coordinate contractors, and improve results. Direct experience re: manufacturing operations and biotechnology processes.
Be able to work in a team-based environment.
Knowledge of programmable logic controllers, industrial controllers, instrumentation, control, computer system or network.
Working Environment:
Will occasionally work in a cleanroom environment and wear special garments (requires removal of make-up and jewelry).
Must occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
Will occasionally be exposed to dust, gases, and fumes, moving equipment and machinery.
Will occasionally work around chemicals such as alcohol, acids, caustics, buffers, bleach and celite that may require respiratory protection.
May occasionally climb ladders and stairs to higher elevations.
May work weekends, evenings, and off-hours, extended periods of time.