Temporary Job - initially for 6 months - Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
DUTIES & RESPONSIBILITITES
Provide technical support to Manufacturing/Packaging/Facilities/Utilities operations in troubleshoot and resolve all automated, electronic, computerized systems and programmable logic-controlled equipment in a timely manner and take proactive, predictive, and preventive measures to assure proper functioning and equipment/systems reliability. This position must comply with all Security guidelines, Environmental Health and safety regulations and the current Good Manufacturing Practices required by the job function.
1. Performs preventive/corrective maintenance to all facilities, utilities, and operations equipment automated and computerized systems, programmable logic controllers (PLCs), ladder logic programs, drives, motion systems, pneumatic, electric, and smart electronic devices.
2. Provides technical support during installation, configuration, integration, troubleshooting, maintenance, qualification, and upgrade for new and existing computerized systems in Manufacturing and Utilities Areas (systems include and not limited to PLCs, HMI, Delta V, Factory Talk, SCADA, DCS/BAS, communication interfaces, networking, printers, report engines, databases, and MES system).
3. Maintains all computer base software of all automated facilities/utilities/operations equipment updated and other tasks related with Automation System.
4. Execute backups, restore and/or disaster recovery process to automated systems in accordance with establish procedures.
5. Develops and/or revises maintenance activities plans and spare parts lists for automated equipment to be added into the Computerized Maintenance Management System (CMMS).
6. Writes and reviews operational and safety SOPs or work instructions for automated equipment and systems; improves and/or develops procedures based on observations and experiences.
7. Prepares reports, fill out records to comply with internal and external regulations.
8. Provides sound problem solving techniques to resolve technical issues and qualification problems.
9. Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
10. Performs process equipment analysis and recommends improvements to existing processes using state-of-the-art computer technology and participates proactively as a team member of implementation projects for new integrated business application and process automation, providing consulting advice in the use and management of technology.
11. Reviews and tests programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level.
12. Contacts hardware or software vendors (if applicable) to report problems and, coordinates and implements vendor recommendations when approved or accepted by the functional area owners and change management process.
13. Assures reported problems are solved by implementing corrective actions like (but not limited) users retraining, changes to existing SOPs, applying software fixes or hardware fixes, information resources colleagues’ recommendations, etc. These activities must comply with current applicable change control procedures.
MINIMUM REQUIREMENTS
- BS in Engineering, Electronics or Computer Science.
- Three (3) years of working experience within an industrial environment with at least two (2) years of relevant combined experience in programmable logic controllers and production maintenance function within a pharmaceutical manufacturing plant.
- Preferred experience with Allen Bradley controllers and/or Rockwell Automation platforms.
- Proven knowledge in process control and automation systems used in the pharmaceutical industry (not limited to): PLCs, SCADAs/HMIs, microcontrollers, single loop controllers, DCS, interfaces and report development.
- Strong Databases and networking knowledge.
- Able to read, interpret, and understands electrical/mechanical drawings, P&IDs and electrical one-line diagrams.
- Ability to troubleshoot problems for highly technical equipment and smart devices.
- Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
- Strong analytical and mathematical calculations skill plus understanding of instrumentation calibration process.
- Broad knowledge of cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
- Good technical writing skills and ability to review SOPs and work instructions.
- Effective written and oral communication skills both Spanish and English.
- Capable to interact with external vendors/customers.
- Capable to plan work schedules and set priorities with a sense of urgency and meet deadlines.
- Customer service oriented.
- Availability to work irregular hours, rotative shifts, weekends and holidays when required due to business needs.
- Able to plan and prioritize multiple activities simultaneously.
- Self-starter and well organized.
- Ability to keep work pace and/or meet deadlines.
- Ability to exercise good judgment.
**Weil Group is proud to be an Equal Employment Opportunity Employer. **
##IND2
Job Types: Full-time, Temporary
Education:
Experience:
- pharmaceutical operations or Manufacturing processes: 5 years (Preferred)
- project management skills: 5 years (Preferred)
- Process automation in pharmaceutical environment: 4 years (Preferred)
- computerized systems validation: 2 years (Preferred)
- computer system life cycle concepts, change control systems: 2 years (Preferred)
- FDA regulatory requirements, including 21 CFR Part 11.: 2 years (Preferred)
- MES Systems: 2 years (Preferred)
- PLC programming, Rockwell Automation platform visualization: 2 years (Preferred)
- data historian, atabases (MS SQL): 2 years (Preferred)
- Computer System Validation (CSV): 2 years (Preferred)
Language:
Work Location: In person
