PRIMARY DUTIES AND RESPONSIBILITIES:
Support ongoing technical operations including: trouble shooting machine, robot, and PLC issues; performing root cause analysis on complex issues; implementing improvements; interfacing with suppliers on supply issues; and reviewing existing procedures or creating new procedures as necessary.
Manage small scale process automation projects; create implementation plans then prioritize activities and closely manage project milestones of assigned projects; identify options and contingencies to keep numerous active projects on track. Work with the Engineering team on larger projects and continuous improvement activities.
Maintain necessary documentation to support the automation such as preventive maintenance procedures, SOPs, training guides, and programs. Train pharmacists, operators, and maintenance personnel on equipment and procedures.
Support the maintenance team by creating and delivering training to maintenance personnel and ensuring knowledge transfer on technical projects. Assist with the identification, organization, and ordering of spare parts. Perform preventive maintenance on automated equipment as needed.
Maintaining appropriate documentation for equipment and processes including change control, drawings, manuals, spare parts lists, and validation.
Write and execute validation protocols and reports related to changes made to the automation equipment and processes.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
1. Associate Degree in technical field with 2+ year s relevant experience, or 5+ year s relevant automation experience in a manufacturing environment, preferably medical device or pharmaceutical.
2. Innovative, decisive, results oriented individual contributor with strong problem-solving skills.
3. Experience with FANUC robots, Allen Bradley PLC's, and AutoCAD/Solidworks preferred.
4. Experience in aseptic processing preferred.
5. Experience with FDA, GMP, cGMP, and ISO standards preferred.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
Must possess the ability to work effectively with all levels of organization.
Must possess excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, and draw valid conclusions.
Must self-driven and capable of working independently with minimal supervision.
Must be proficient in Microsoft Word, Excel, and Outlook.