Automation and Systems Subject Matter Expert (SME)

Weil Group, Inc; Puerto Rico; On-site; USD 120,000 - 160,000; Full time

Job summary

Weil Group, Inc. seeks an Automation and Systems Subject Matter Expert (SME) to provide advanced technical expertise for Capital Projects and Manufacturing/Utilities systems. The role covers system design, configuration, testing, commissioning, and validation activities.

Key responsibilities include supporting PLCs, SCADA, HMI, DCS/BAS, MES and data interfaces, plus vendor coordination and change control in a GMP environment. Fluency in English and Spanish is required.

Qualifications

• BS in electrical, computer, mechanical engineering or related field.
• 5+ years in pharmaceutical operations or manufacturing with 4 years in process automation in pharma.
• Experience with computerized systems validation & FDA 21 CFR Part 11.

Responsibilities

• Provide automation and systems SME support for Capital Projects and operations.
• Configure, troubleshoot, calibrate, qualify, and validate manufacturing/utility systems (PLC, HMI, SCADA, DCS, BAS).
• Develop design specs, functional requirements, and validation protocols.
• Collaborate with Manufacturing, Quality, IT, and Engineering teams on projects and changes.
• Lead change control, CAPA, audits support, and data integrity efforts.

Skills

Bilingual English/Spanish

Project management

Pharma manufacturing

PLC programming

System validation

Technical troubleshooting

Cross-functional collaboration

Education

BS in electrical/computer/mechanical engineering

Pharma/ GMP knowledge

Tools

Rockwell Automation

OSi PI/ FactoryTalk Historian

MS SQL

SCADA

VMware vSphere

Maximo (preferred)

Job description

Automation and Systems Subject Matter Expert (SME)

• Biotech/Pharmaceutical

The Automation/Systems SME Support role provides specialized technical expertise and execution support for Capital Projects, as well as operational support for Manufacturing and Utilities systems. The resource acts as the Automation & Systems Subject Matter Expert (SME) for assigned Capital Projects, supporting system design, configuration, testing, commissioning, and validation activities.

Key activities or tasks:

• Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Manufacturing and Utilities Areas.
• 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, Factory Talk, SCADA, DCS/BAS, communication interfaces, networking, printers, report engines, databases and MES system).
• 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.
• 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.
• Collaborate with multidisciplinary teams (Manufacturing, Quality, IT, Engineering, etc.) on operational and/or project activities, including providing progress updates on assigned tasks or assessments as needed.
• 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.
• 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.
• 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 ensure software works as expected before installing it in the user environment.
• Review and evaluate proposed design changes to ensure alignment with Client requirements, cGMP, and data integrity best practices.
• Evaluates and closes change control requirements and documentation assuring the validated and compliance state of the environment.
• Assist in quality events investigations, internal audits, CAPA and standalone processes related to Manufacturing/Engineering/Laboratory computerized systems, MES related applications and systems.
• Provides project status using project plans and performs 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.
• 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.
• Develops and/or reviews automation and computerized system related procedures such as: Operational, Maintenance, Security, Backup and Restore, and Disaster Recovery.
• Contacts hardware or software vendors (if applicable) to report or address problems. Coordinate and implement vendor recommendations.
• Assured 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.
• Completes CAPAs, standalone actions, assessments required as part of Quality Systems and/or Reliability program related to automation and computerized systems.
• Assist in the management of Capital Appropriation Requests (CAR’s), and timeline of process automation projects and implementation and support Process Automation initiatives.
• Provides necessary support for Data Integrity and Cyber Security program and initiatives
• Support in the execution of the Computer System Validation (CSV) program for automated and computerized systems processes.
• Keeps abreast with current technology.

Resources Qualifications

• 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 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 understand 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 relationships with internal and external customers 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.
• Strong interpersonal skills to establish and maintain effective working relationships across all organizational levels and disciplines.
• Ability to keep work pace and/or meet deadlines.
• Ability to exercise good judgment.

Preferred:

• Experience with CMMS (Maximo) system preferred.
• High degree Knowledge and experience in Rockwell Automation Platforms
• Knowledge and experience in Siemens systems.
• Knowledge and experience in Wonderware software.
• Knowledge and experience with virtualization software VMWare vSphere.
• Knowledge and experience with Microsoft SQL Database.
• Knowledge and experience in OSI Soft AVEVA PI System.
• Knowledge and experience in Factory Talk Batch.
• Knowledge and experience in MES Syncade system.

Weil Group is proud to be an Equal Employment Opportunity Employer.