drjobs Sr. Automation Engineer

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Job Location drjobs

Lexington, KY - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Our Work Matters

At Kindeva we make products that save lives ensuring better health and well-being for patients around the world.

The Impact You Will Make: As an Automation Engineer you will play a vital role in designing implementing and maintaining automated systems to support pharmaceutical manufacturing in a cGMP environment. Your expertise will drive efficiency improve equipment performance and enhance product reliability. This role combines hands-on technical leadership with cross-functional collaboration to ensure automation systems meet operational needs and regulatory standards. Your work will support both innovation and day-to-day performance ensuring continued compliance safety and productivity in a fast-paced high-impact setting.

Responsibilities:

System Design and Development

  • Design develop and implement automated systems including software hardware and processes.
  • Analyze existing systems identify areas for automation and create solutions that meet specific needs.
  • Configure and/or manage site-level automation systems (e.g. serialization data historian reporting industrial networking).
  • Lead the design and procurement of new process and utility equipment and lead installation start-up commissioning or qualification activities including authoring and/or reviewing IQ/OQ/PQ protocols test execution and authoring summary reports.
  • Support the development of site automation standardization and/or technology master plans.

Programming and Scripting

  • Write scripts and code to automate tasks processes and workflows using various programming languages.

Testing and Optimization

  • Test and optimize automated systems to ensure they function correctly and efficiently.
  • Identify and resolve issues and continuously improve system performance.
  • Implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products.

Troubleshooting and Maintenance

  • Troubleshoot and resolve issues with automated systems ensuring they operate smoothly.
  • Diagnose problems implement fixes and perform maintenance tasks.
  • Support maintenance activities including review and approval of preventative maintenance tasks calibration tolerances and intervals drawing updates execution of automation-related PMs (e.g. backup/restore) and support of out-of-tolerance investigations related to instrument calibrations.

Collaboration and Communication

  • Collaborate with other engineers technicians and stakeholders to develop and implement automation solutions.
  • Effectively communicate technical information and ensure project success.
  • Provide support to Manufacturing Quality Maintenance and Validation for deviation investigations change controls and CAPAs through participation on cross-functional teams.
  • Participate in plant engineering maintenance and calibration activities as needed.

Qualifications:

Basic Qualifications:

  • BS in engineering/related degree or equivalent experience.
  • 8 years of related experience; or 6 years with a Masters degree.
  • Experience with a variety of PLCs HMI hardware and industrial sensors and applications.
  • Controls design experience.
  • General electrical design knowledge.

Preferred Qualifications:

  • Working knowledge of cGMP GAMP5 and regulatory requirements.
  • Experience working with nasal spray products and devices or related drug-delivery devices.
  • Industrial networking and server management.
  • Technical writing experience such as: SOPs Maintenance PMs user requirement specs vendor requests for proposal.
  • Experience with site-level automation systems such as:
    • Serialization: Antares Tracelink
    • Data historian: Aveva OSI PI
    • Reporting systems: OSI PI MS Report Builder SQL Development
    • Kepware Matrikon AB Factory Talk
    • Automated Visual Inspection

Physical Requirements:

  • Specific vision requirements include close vision distance vision color vision and the ability to adjust and focus to read/understand/execute documentation as required by the position.
  • Employees are required to follow all cGMP and safety procedures.
  • The employee must wear all required safety equipment and safely perform assigned work.
  • Employees must use proper lifting techniques and be conscious of hazards around them.
  • Must follow all GMP and safety procedures within the department.
  • The employee must occasionally lift and/or move up to 20 pounds.

Required Experience:

Senior IC

Employment Type

Full-Time

Company Industry

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