Sr. Automation Engineer (31806) – Juncos, PR

Requirements Education/Experience
Master’s degree in engineering and 3 years of experience in the Pharmaceutical or Biotechnology industries OR Bachelor’s degree in Engineering and 5 years of experience in the Pharmaceutical or Biotechnology industries

Engineering degree (control, electrical, mechanical, chemical, industrial)
Software requirement: Rockwell Software Platform

Preferred Qualifications
• Experience in the support of Validation activities
• Knowledge and used of system as MAXIMO, Trackwise
• Ability to handle multiple projects at one time
• Work experience in pharmaceutical manufacturing automation systems maintenance
• Experience with Rockwell Automation systems (ControlLogix, RSView, RSBatch, Communication Network (CNet\DNet\Ethernet) preferred.
• Knowledge of ASTM 2500, ISA S88 and S95 standards.
• Experience with OSI PI Historian (PI ProcessBook, BatchView and Datalink)
• Troubleshooting experience with Automation systems is desired
• Troubleshooting experience with Cell Culture/Purification process/systems is desired
• Knowledge in programing language (e.g., VBA)
• Data integrity knowledge and application
• ISA Certified Automation Professional

Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.

This position provides an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

1. Complete complex or novel assignments.
2. Support non-standard shift organization including extended hours.
3. Development of new and/or improved engineering techniques and procedures.
4. Develop engineering policies and procedures that affect multiple organizational units.
5. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
6. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
7. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
8. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
9. Application of mature engineering knowledge in planning and conducting projects.
10. Prompt and regular attendance to workplace.
11. Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing recommendations for large and/or highly complex system/facility modifications.
12. Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
13. Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
14. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
15. Develop technical solutions to complex problems using the ingenuity and creativity.
16. Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems , Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
17. Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
18. Develop of detailed specification, engineering documents, SOP and operating standards.
19. Interacts effectively with variety of communication and working styles.
20. Management of contractors and vendors.
21. Troubleshoot and resolve equipment, automation or process issues in the field.
22. Working closely with multiple disciplines, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
23. Lead technical root cause analysis, incident investigations, and troubleshooting on process control issues related to instrumentation and control systems.
24. Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs.

Doctorate degree OR Master’s degree in Engineering and 3 years of experience in the Pharmaceutical or Biotechnology industries OR Bachelor’s degree in Engineering and 5 years of experience in the Pharmaceutical or Biotechnology industries.

1. 5+ years of engineering experience in a manufacturing support environment with at least 3 years’ experience in the Pharmaceutical or Biotechnology industries.
2. Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services.
3. Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems. 4. Experience with Tech Transfer, Process Design, Commissioning, validation and change control methodology.
5. Direct experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of cGMPs.
6. Excellent written and verbal communication skills and the ability to work with minimum direction.
7. Interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
8. Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.
9. Ability to lead and influence cross-functional teams and embrace a team-based culture.
10. In-depth knowledge on Rockwell Automation Platform and Allen-Bradley PLCs:
• Rockwell Automation Factory Talk & ControlLogix PLC Platform.
• Rockwell PLC5/SLC500 PLC families Controllers.
• Rockwell Automation RSView SE and FTBatch systems.
• DeviceNet technologies.
11. Strong knowledge in programing language (e.g., VBA)
12. Direct hands-on experience with lifecycle management of Rockwell hardware and software infrastructure preferred.
13. Understanding of Operational Excellence and Lean transformation in the automation and engineering Context.
14. Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation. 15. Knowledge of ASTM 2500, ISA S88 and S95 techniques. – Batch processing a desired advantage.
16. Work schedule flexibility to support 24/7 operations and after-hours engineering coverage. 17. Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
18. ISA Certified Automation Professional.
19. Familiarity with validation processes and documentation in a highly regulated environment. 20. Ability to interpret and apply GMPs in addition the application of engineering science to production.
21. Able to develop solutions to routine technical problems of limited scope.
22. Comprehensive understanding of validation protocol execution and knowledge of validation processes as applied to new equipment installations.
23. Skills in the following areas:
• Problem solving and applied engineering
• Basic technical report writing
• Verbal and writing communications in English and Spanish
• Basic technical presentations
• Personal Organization
• Validation Protocol Writing
• Dealing with and managing change
• Computer Literacy
• Facilitation
• Collaboration
• Basic project management
• Completion and follow-up
• Negotiation, persuasion and facilitation
• Project cost development
• Conflict Resolution
• Leadership and teambuilding
• Specialized equipment/process expertise
• Ability to independently determine when additional internal resources are needed to solve problems and to handle multiple projects at one time.
• Established expertise in at least 3 separate areas of engineering technology.
• Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
• Problem solving skills with the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Working knowledge of financial analysis tools.
• Ability to delegate and manage the project work of others.
• Strong process control systems automation background.
• Design, installation, programming and validation of automated processes.