Provide technical skills and expertise to: (1) support ongoing technical operations and (2) implement new equipment and process improvements. Provide technical skills and abilities to assure projects meet schedule and budget commitments. Success is measured through the generation and implementation of projects that meet the desired outcome, budget, timeline, and processing goals. Some travel is required during equipment commissioning at the various compounding centers.
PRIMARY DUTIES AND RESPONSIBILITIES:
• Support ongoing technical operations at all compounding centers including: trouble shooting machine, robot, and PLC issues; performing root cause analysis on complex issues; creating project plans and implementing improvements; interfacing with suppliers on supply issues; ensuring process (Change Work) compliance; and reviewing existing procedures or creating new procedures as necessary.
• Enhance engineering systems by assisting with the development of detailed equipment configuration files, troubleshooting guides, organized file storage, and continuous improvement procedures.
• Enhance maintenance function by: working with Facilities Engineering Manager to identify gaps in maintenance skill sets, creating and delivering training to maintenance personnel, and ensuring knowledge transfer on technical projects.
• Commission or decommission new or existing equipment across all compounding centers.
• Implement new, improved, and/or expanded equipment, tooling, fixturing, and processes for new and existing service offerings. Includes responsibility for defining process requirements, budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.
• Manage small to medium 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.
• Develop and implement necessary SOPs and training materials; train pharmacists, operators, and maintenance personnel on equipment and SOPs; establish processing, packaging, and test specifications for products and equipment.
• Write, review, and execute validation protocols and reports; perform validations of new automation equipment, processes, water systems, and other process related equipment.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
• BSME or equivalent, Associate Degree in technical field.
• 5+ year’s relevant experience, or 10+ year’s relevant process engineering experience in a manufacturing environment, preferably medical device or pharmaceutical.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
• Innovative, decisive, results oriented individual contributor with strong problem-solving skills.
• 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, statistically evaluate solutions, and draw valid conclusions.
• Demonstrated results process improvements on time, within budget, and meeting specified requirements.
• Experience in aseptic processing preferred.
• Very familiar with FDA, GMP, and ISO standards.
• Must be proficient in Microsoft Word, Project, Excel, and Outlook.
• Prefer experience with Fanuc robots, Allen Bradley PLCs, and AutoCAD.