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Job Description:
Must-Have
Engineering
- Oversees a group of Maintenance Technicians in an GMP environment. Ensure GMP and EHS compliance of all colleagues while in operation.
- Develop, maintains and review of all Corrective, Preventative Maintenance, Good Manufacturing Practice work orders in the Computerized Maintenance Management System (EAMS).
- Provides technical leadership in the development and utilization of Clean-Inspect-Lubricate (CIL) and Centerlines during TPM implementation
- Ensures equipment is maintained at basic condition and deliver PM’s in the scheduled time frame
- Ensures the proper functioning of the instruments and systems of instrumentation, measurement, control, to ensure measurement correct set parameters
- Provides leadership in troubleshooting and problem-solving breakdowns and reliability losses with cross-functional team
- Work with purchasing, contractors, outside firms, and suppliers to support the maintenance department
- Become a subject matter expert for site quality investigations from Maintenance & Automation
- Contact vendors for support and emergency repair items when required
- Write QARs which relate to Maintenance and Automation part
- Maintain user access records, backups and restores of PLC’s/Computer Systems/Vision Systems, Generate Audit trails and review for Data integrity in Pharmaceutical Manufacturing plants. Recommend upgrades and repairs to manufacturing lines and systems
- Troubleshoot advanced PLC Controls systems, Preventive Maintenance and Repairs to Validated Manufacturing Systems.
- Active participate in daily Tier 1 Engineering meetings to verify plant priorities daily
- Perform electrical walkdown, startups, installation of new equipment and upgrades.
- Able to re-program and changes to various VFDs and PLC software systems. Provide support and advice to the Equipment Installation, Qualification & Commissioning
- Prepare functional procedures and documentation for technical detail on Maintenance and Automation area
- Leading all the site Automation project such as ICS Cyber program, CLAN infrastructure & migration, Alarm Management, and other CAPEX project which relate to Automation.
Must-Have
- Bachelor's Degree
- 3+ years of experience pharmaceutical aseptic manufacturing experience
- Strong understanding in GMP
- Good experience in equipment automation, equipment maintenance management
- Direct supervisory experience and understands knowledge management
- Knowledge of Good Manufacturing Practices {also cGMP} OSHA, Food and Drug Administration and environmental regulations applicable to the pharmaceutical Industry
- Strong people management experience
- Strong English speaking and writing skills
- Good computer skills in Microsoft Office suite of products
- Master's degree
- Relevant pharmaceutical experience
- Hands on experience with communication protocols
- Strong technical skills
- Certified Sig Sigma Yellow Belt
- Lean manufacturing trained
Engineering