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Engineering - Senior Process Automation Specialist
Manati, PR · Biotech/PharmaceuticalDUTIES & RESPONSIBILITITES
Provides support to the automation and computerized systems by enhancing troubleshooting techniques, leading complex troubleshooting activities and implementing improvements while assuring operations continuity and reliability for the Manufacturing and Utilities Areas. Performs process analysis and recommends/implements improvements to existing processes with state-of-the-art automated and computer technology. Coordinates and executes the installation, troubleshooting, maintenance, qualification and upgrade for new and existing computerized systems. Performs project management functions for the execution, implementation and start-up of new automated computerized systems. 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. Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Manufacturing and Utilities Areas.
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. Perform software or hardware changes to automation and computerized systems by developing analysis, recommending improvements to existing processes through the use of state-of-the-art computer technology.
4. Participates proactively as a team member of implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology.
5. Installs, configures, troubleshoots, and maintains computerized systems in Manufacturing and Utilities Areas. These systems include (not limited to), PLCs, SCADA, and Fourth generation languages for interfaces and report development.
6. Provides user training and continuous support to assure proper use of the software applications following established operational procedures and user support during problem solving situations associated with systems implementation.
7. Reviews and test programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level. Perform changes to applications or to their corresponding configurations to assure software works as expected before installing it in the user environment.
8. Evaluates and closes change control requirements and documentation assuring the validated and compliance state of the environments.
9. Assist on quality events investigations, internal audits, CAPA and standalone processes related Manufacturing/Engineering/Laboratory computerized systems, MES related applications and systems.
10. Provides project status using project plans and perform best efforts to achieve projects milestones within the pre-established due dates. Provides alternatives and problem solving initiatives during possible project delays or possible showstoppers.
11. Support the standards or strategy definition for software automation, system integration, minimum requirements for plant automation through analysis and design/re-design of current systems and processes.
12. Develops and/or reviews automation and computerized system related procedures such as: Operational, Maintenance, Security, Backup and Restore, and Disaster Recovery.
13. Contacts hardware or software vendors (if applicable) to report or address problems. Coordinate and implement vendor recommendations.
14. Assures reported problems are solved by implementing corrective actions like (but not limited) user 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.
15. Completes CAPAs, standalone actions, assessments required as part of Quality Systems and/or Reliability program related to automation and computerized systems.
16. Assist in the management of Capital Appropriation Requests (CAR’s), and timeline of process automation projects and implementation and support Process Automation initiatives.
17. Provides necessary support for Data Integrity and Cyber Security program and initiatives
18. Support in the execution of the Computer System Validation (CSV) program for automated and computerized systems processes.
19. Keeps abreast with current technology.
MINIMUM REQUIREMENTS
• BS in electrical, computer, mechanical engineering and or related fields.
• Five-(5) years of experience in pharmaceutical operations or Manufacturing processes with proven project management skills which four (4) of the five years’ experience, must be in Process automation in pharmaceutical environment with two (2) years’ experience in computerized systems validation.
• Proficient knowledge of computer system life cycle concepts, change control systems and FDA regulatory requirements, including 21 CFR Part 11.
• Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
• In-depth knowledge of the science and physics involved in the design, installation, commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment.
• Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
• Experience with external and internal regulatory audits (FDA, EMA, Otsuka, Sanofi, etc.).
• Knowledge of pharmaceutical business processes and equipment.
• Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
• Proven skills in projects management, systems development and implementation of manufacturing, MES Systems, and quality related systems.
• Ability to manage and operate computer software packages used for data acquisition systems and PLC programming, including (not limited to) Rockwell Automation platform visualization and programming solutions/tools.
• Knowledge of data historian (including, but not limited to OSI PI-FactoryTalk Historian), Databases (MS SQL) and networking infrastructure and topologies.
• Able to read, interpret, and understands electrical/mechanical drawings.
• Ability to review SOPs and work instructions.
• Flexible and responsible.
• Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data.
• Bilingual English/Spanish, both written and verbal are required.
• Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customer’s at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
• Able to plan and prioritize multiple complex activities simultaneously (i.e., installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.
• Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
• 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.**
Provides support to the automation and computerized systems by enhancing troubleshooting techniques, leading complex troubleshooting activities and implementing improvements while assuring operations continuity and reliability for the Manufacturing and Utilities Areas. Performs process analysis and recommends/implements improvements to existing processes with state-of-the-art automated and computer technology. Coordinates and executes the installation, troubleshooting, maintenance, qualification and upgrade for new and existing computerized systems. Performs project management functions for the execution, implementation and start-up of new automated computerized systems. 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. Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Manufacturing and Utilities Areas.
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. Perform software or hardware changes to automation and computerized systems by developing analysis, recommending improvements to existing processes through the use of state-of-the-art computer technology.
4. Participates proactively as a team member of implementation projects for new integrated business application and processes automation, providing consulting advice in the use and management of technology.
5. Installs, configures, troubleshoots, and maintains computerized systems in Manufacturing and Utilities Areas. These systems include (not limited to), PLCs, SCADA, and Fourth generation languages for interfaces and report development.
6. Provides user training and continuous support to assure proper use of the software applications following established operational procedures and user support during problem solving situations associated with systems implementation.
7. Reviews and test programs to ensure that they meet manufacturers recommend requirements for hardware and software at the personal computer and/or host computer system level. Perform changes to applications or to their corresponding configurations to assure software works as expected before installing it in the user environment.
8. Evaluates and closes change control requirements and documentation assuring the validated and compliance state of the environments.
9. Assist on quality events investigations, internal audits, CAPA and standalone processes related Manufacturing/Engineering/Laboratory computerized systems, MES related applications and systems.
10. Provides project status using project plans and perform best efforts to achieve projects milestones within the pre-established due dates. Provides alternatives and problem solving initiatives during possible project delays or possible showstoppers.
11. Support the standards or strategy definition for software automation, system integration, minimum requirements for plant automation through analysis and design/re-design of current systems and processes.
12. Develops and/or reviews automation and computerized system related procedures such as: Operational, Maintenance, Security, Backup and Restore, and Disaster Recovery.
13. Contacts hardware or software vendors (if applicable) to report or address problems. Coordinate and implement vendor recommendations.
14. Assures reported problems are solved by implementing corrective actions like (but not limited) user 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.
15. Completes CAPAs, standalone actions, assessments required as part of Quality Systems and/or Reliability program related to automation and computerized systems.
16. Assist in the management of Capital Appropriation Requests (CAR’s), and timeline of process automation projects and implementation and support Process Automation initiatives.
17. Provides necessary support for Data Integrity and Cyber Security program and initiatives
18. Support in the execution of the Computer System Validation (CSV) program for automated and computerized systems processes.
19. Keeps abreast with current technology.
MINIMUM REQUIREMENTS
• BS in electrical, computer, mechanical engineering and or related fields.
• Five-(5) years of experience in pharmaceutical operations or Manufacturing processes with proven project management skills which four (4) of the five years’ experience, must be in Process automation in pharmaceutical environment with two (2) years’ experience in computerized systems validation.
• Proficient knowledge of computer system life cycle concepts, change control systems and FDA regulatory requirements, including 21 CFR Part 11.
• Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications.
• In-depth knowledge of the science and physics involved in the design, installation, commissioning and validation/qualification of computerized systems and PLCs as applied to pharmaceutical production environment.
• Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.
• Experience with external and internal regulatory audits (FDA, EMA, Otsuka, Sanofi, etc.).
• Knowledge of pharmaceutical business processes and equipment.
• Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
• Proven skills in projects management, systems development and implementation of manufacturing, MES Systems, and quality related systems.
• Ability to manage and operate computer software packages used for data acquisition systems and PLC programming, including (not limited to) Rockwell Automation platform visualization and programming solutions/tools.
• Knowledge of data historian (including, but not limited to OSI PI-FactoryTalk Historian), Databases (MS SQL) and networking infrastructure and topologies.
• Able to read, interpret, and understands electrical/mechanical drawings.
• Ability to review SOPs and work instructions.
• Flexible and responsible.
• Significant abilities and aptitude to analyze data detecting inconsistencies, determining relative importance and to solve complex technical situations based on data.
• Bilingual English/Spanish, both written and verbal are required.
• Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customer’s at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
• Able to plan and prioritize multiple complex activities simultaneously (i.e., installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.
• Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary.
• 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.**