ROLE SUMMARYThis is a great opportunity to support commercial manufacturing operations within a 24/7 pharmaceutical manufacturing environment by providing technical support, troubleshooting processes, continuous improvement, and project execution. This individual will be supporting assigned production lines, driving corrective actions, and executing engineering deliverables that improve safety, quality, reliability, and productivity.
ROLE RESPONSIBILITIESManufacturing Support (24/7 Facility)- Provide daily technical support for assigned production lines.
- Support troubleshooting of equipment, process, and quality issues.
- Participate in root cause investigations and corrective actions.
- Escalate significant production risks appropriately.
- Support line recovery efforts during downtime events.
- Maintain visibility online performance, downtime losses, and recurring issues
Process Ownership & Optimization- Serve as engineering owner for assigned manufacturing processes.
- Manage assigned action items and corrective actions to closure.
- Support OEE, uptime, yield, scrap reduction, and throughput improvements.
- Develop and implement process improvements.
- Support validation, qualifications, and change-control activities.
- Maintain technical documentation and engineering records
CAPA, Quality, and Compliance- Support investigations, deviations, and CAPAs.
- Complete assigned quality actions by committed due dates.
- Maintain compliance with cGMP requirements.
- Support audits and inspection readiness activities.
- Participate in Engineering Change Control processes)
Project Execution- Execute assigned engineering projects and deliverables.
- Manage multiple assignments simultaneously.
- Communicate project risks and delays proactively.
- Meet agreed-upon completion dates.
- Provide regular status updates to management.
- Support implementation of capital and continuous improvement projects
QUALIFICATIONSRequired- Bachelor's degree in mechanical, electrical, systems engineering, manufacturing or other engineering discipline from an accredited institution or a bachelor's degree with manufacturing experience.
- 3+ years in pharma/biotech/medical device manufacturing is preferred.
- Working knowledge of root cause investigation methodologies and corrective action development.
- Working knowledge of cGMP requirements, quality systems, change control, deviations, and CAPA processes.
- Experience troubleshooting manufacturing processes, equipment, and production issues.
- Ability to manage multiple assignments and priorities simultaneously.
- Demonstrated ability to execute engineering projects from concept through implementation.
- Strong written and verbal communication skills.
- Experience supporting manufacturing operations in a production environment.
- Proficiency with Microsoft Office applications and engineering documentation systems.
- Ability to work effectively with Production, Maintenance, Quality, Validation, and Engineering teams.
- Willingness to provide support within a 24/7 manufacturing operation when business conditions require additional engagement.
Preferred - Familiarity with automated systems and MES.
- Experience with Lean Manufacturing, Six Sigma, DMAIC, Kaizen, SPC, or DOE methodologies.
- Experience participating in equipment qualifications, validations, and commissioning activities.
- Familiarity with RCAs, CAPAs, deviations, and investigation systems.
- Experience supporting OEE, downtime reduction, scrap reduction, and productivity improvement initiatives.
- Expertise in inhalation or transdermal manufacturing is preferred.
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