Senior Automation Engineer - Lexington, United States - Kindeva Drug Delivery

Description

Job Details

Job Location
Company Headquarters - Lexington, KY

Position Type
Full Time

Job Category
Engineering

Description


Summary:

The Senior Automation Engineer is responsible for performing and/or leading a wide-array of control systems development, maintenance and engineering activities in a pharmaceutical cGMP environment.

These activities include designing studies, coordinating change management, writing/executing protocols for testing equipment/systems, and summarizing results. Candidate will also assist in equipment troubleshooting, equipment and facility design, and controls related activities.

This position is also responsible for the development and /or technology transfer of new solutions and modifications to our existing manufacturing process automation systems to solve process problems, optimize equipment performance and reliability.

Essential Duties:
Lead projects or participate on project teams to implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products
Configure and/or manage site level automation systems (ex: serialization, data historian)
Lead the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports
Design and execute studies as required to investigate, optimize, troubleshoot, and implement equipment improvements
Work on multiple projects simultaneously and coordinate test work with various other departments
Lead the development and implementation of automation improvement changes
Development of site automation standardization and/or technology master plan.
Champion equipment improvement projects and ensure equipment and systems remain in a qualified state
Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services
Point person for equipment improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols
Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPA's through participation on cross functional teams
Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, execution of automation related PMs (ex: backup/restore) and support of out-of-tolerance investigations related to instrument calibrations
Participate in plant engineering, maintenance and calibration activities as needed
Other duties as assigned

Qualifications

BS in engineering or related life science
Greater than 7 years of previous work experience in a related field
Ability to maintain focus on tasks until completion and think analytically to solve problems
Working knowledge of cGMPs and regulatory requirements is preferred
Good mechanical aptitude
Good interpersonal skills and the ability to work well in a team environment
Excellent technical writing and organizational skills; extremely detail oriented
Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment
Ability to work independently with minimal technical supervision
Strong listening, writing, reading, and verbal communication skills
Experience working with nasal spray products is a plus
Experience with a variety of PLC and HMI hardware and applications
Experience with site level automation systems (ex: serialization, data historian)
Controls design experience
General electrical design knowledge

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