Automation Engineer II - AP Formulation/WS
BioSpace · Clayton, NC · 3 wk ago
EngineeringFull-time
About the role
The Automation Engineer II - AP Formulation/WS position is part of the Fill & Finish Expansions (FFEx) department within Novo Nordisk. FFEx is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across various production areas.
Responsibilities
- Ensure new processes & equipment are compliant with line of business and global standards.
- Participate in local & global team to ensure new equipment & processes are designed to meet URS & IFA designed by Novo Nordisk ensuring the equipment will be ready for install & qualification as well as successful ramp up of equipment.
- Improve reliability of the process control systems to meet current & projected customer, business & regulatory requirements through focus on people & equipment, as well as serving as gatekeeper for standards.
Relationships
Reports to Manager, Senior Manager.
Essential Functions
- Work with local & global project team to ensure design of process is compliant with local & global standards.
- Develop interface agreements & align requirements with equipment vendors.
- Develop & implement plans to maintain & improve process control systems.
- Schedule & execute plans in coordination with manufacturing schedules.
- Aid in developing & managing expense budgets for maintaining & improving process control systems.
- Own self development & initiative to understand the site process control systems.
- Support audits & inspections as SME for process control systems.
- Coach & train colleagues & stakeholders in relevant areas.
- Utilize the appropriate cLEAN® tools within the main areas of Systematic Problem Solving, process improvement, & project management.
- Operate within compliance with a quality mindset that focuses on risk management & mitigation.
- Implement effective change management.
- Support Corporate, PS, local IT, & local stakeholder initiatives & projects.
- Participate in the development of new SOPs, best practices, and maintenance procedures.
- Follow all safety & environmental requirements in the performance of duties.
Qualifications
- Bachelor's Degree in engineering/related field of study from an accredited university required.
- May consider a minimum of seven (7) years of engineering experience in process-based manufacturing, utility, &/or packaging systems required.
- May consider a High School Degree/GED with a minimum of nine (9) years of engineering experience in process-based manufacturing, utility, &/or packaging systems required.
- Minimum of five (5) years engineering experience in process-based manufacturing, utility, &/or packaging systems required.
- For Logistics roles only: Warehouse automation equipment preferred (Automated storage and Retrieval Systems, Automated Guided vehicles, Autonomous Mobile Robots, and Conveyor systems).
- Knowledgeable in the following technologies: SAP EM, PLC, DCS/SCADA, MES, Oracle, MS SQL (databases), Historian, general controls a plus SAP EWM a plus.
- Ability to demonstrate proven expertise (e.g., project management) in planning/organization & project execution, follow-up, & completion required.
- Ability to translate high level direction into actionable tasks that deliver results using cLEAN® / Six Sigma methodologies a plus.