Sr. Automation Engineer

Job Title

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Summary Of Role

Ensures the continue operations of all Process Equipment including programming and ongoing maintenance for Manufacturing and Utilities Areas.

Responsibilities

Provides technical support during installation, configuration, integration, troubleshooting, maintenance, qualification and upgrade for new and existing computerized systems in Manufacturing and Utilities Areas.

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.

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.

Perform changes to applications or to their corresponding configurations to assure software works as expected before installing it in the user environment.

Review and evaluate proposed design changes to ensure alignment with cGMP, and data integrity best practices.

Evaluates and closes change control requirements and documentation assuring the validated and compliance state of the environments.

Assist on quality events investigations, internal audits, CAPA and standalone processes related Manufacturing/Engineering/Laboratory computerized systems, MES related applications and systems.

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.

Develops and/or reviews automation and computerized system related procedures such as: Operational, Maintenance, Security, Backup and Restore, and Disaster Recovery.

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.

Location

Manatí, PR

Education

BS in electrical, computer, mechanical engineering and or related fields.

Preferred Qualifications

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.

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.

Skills

Broad knowledge of relevant governmental regulations, cGMPs and guidelines pertaining to a biopharmaceutical manufacturing plant.

Knowledge of pharmaceutical business processes and equipment.

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.

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 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.

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.

This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.