Our client seeks the services of capable vendors to support the operation and/or capital projects
in the following key activities or tasks (but not limited to) the support services:
• 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, Delta V,
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.
• 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
assure software works as expected before installing it in the user environment.
• 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.
• 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.
• 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.
• 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 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 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.
• 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.
About the Company:
We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.