Description

This Automation Specialist will support Boehringer Ingelheim AH Puerto Rico site to ensure that the local business own computer systems and automation equipment are operational. The scope includes automation systems and equipment that supports manufacturing, packaging, engineering and utilities and other similar systems. The resource will be primary focus to ensure reliable and smooth operation of the systems/equipment by providing on site and on call support as follows:

Incident management: technical troubleshooting, failure and Root cause analysis.
Compliance: CAPAs, Problem Reports, Change Control, Performance Review
Improvements: System configurations and programming changes as per CAPAs

The incumbent will execute most of the time as the System Lead for Business Own applications/equipment/systems in the site to ensure the systems works as per design and keeps the validated state. The position will reports to a manager level or technical lead level with moderate supervision. It will not have internal direct reports however may lead contractors during projects or similar activities. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

Responsible for execute failure analysis, troubleshooting, root cause analysis and similar hands on activities conducting to maintained the computer and automation systems operational.
Support the configuration, administration and maintenance activities of the sites automation systems including process control, building automation, manufacturing, and Packaging. The position act as the system lead and/or SME as required for the Business Own systems.
Support the site compliance by ensuring computer validation requirements through the system and equipment end-to-end SDLC process, including change control, incident management, configuration management, qualification/Validation.
Support and facilitates projects implementation
Support the site Validation Manager to implement and maintain corporate guidance, policies and procedures required for the automation systems and equipment such as update CMDB Inventory, implement IS Security controls, Data Integrity, Patch management, Virus protection, Rick assessments and mitigations.
Assist in and/or lead in the design, development, and qualification of automated processes, equipment, and systems. This includes project implementation support and enhancements.
Identify opportunities to improve existing automation processes, equipment, systems, and infrastructure.
This position will not have internal direct reports; however, supervision of contractors may be necessary especially during projects.

Requirements

Bachelor degree from an accredited institution in Engineering, Computer Science or related technological field with equivalent experience
Three years (3) or more of relevant working experience on automation process control (Manufacturing and Packaging), computer/equipment qualifications, System Life Cycle methodology in a pharmaceutical or FDA regulated environment.
General understanding of external regulations e.g. 21CFR Part 11, Annex 11, GAMP
Hands-on experience on system Lead or system administration activities including generation and execution of Change control, configuration management, Incident management, access account management, and PLC logic analysis.
Strong experience with Allen Bradley PLC, OSISoft PI historian, Rockwell Software SCADA, Instrumentation and control panel hardware as required by the job.
Strong experience with computer systems validation practices (GAMP) and SDLC methodology.
Experience authoring and reviewing Requirements specifications, Design specifications, Automation IQ and OQ, standard operating procedures, on-the-job-trainings, and other controlled documents.
General knowledge on IT Infrastructure environment (Network, Servers, Data Base)
Experience supporting and/or managing projects
Knowledge of PLC programming, basic windows/servers configuration, experience on creation and/or modification of automated systems programs.
Proficient in planning and coordinating small project relevant activities.
Knowledge of cGMPs, EMEA, Safety regulations, and CSV philosophy
Work experience with Office (Word, Excel, PowerPoint, Outlook)

Desired Experience, Skills, and Abilities:

PE or EIT Certified

Eligibility Requirements:

Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.