Senior Technology Professional at QRC Group, Inc

Canóvanas, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Processes, Computer Systems Validation, Process Control, Process Analytical Technology, Software Programming, Technical Support, Project Management, Troubleshooting, PLC Programming, SCADA, HVAC, Documentation, Risk Assessment, User Specifications, Factory Acceptance Test, Installation Qualification, Operation Qualification

Industry

Staffing and Recruiting

Description

Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description Senior Technology Professional with expertise in pharmaceutical processes, equipment/computer systems specifications, operations, troubleshooting, qualification and validation, instrumentation, process control, Process Analytical Technology (PAT), software programming/configuration and related technical support. Will coordinate and conduct Computer System Validation and qualification to required systems and equipment. Develops and maintains administration and support model for process controls systems following applicable procedures. Provides and coordinates technical support for manufacturing, bulk packaging and lab equipment/systems. Assures that all assigned projects are conducted in compliance and following procedures and guidelines. Provides leadership and advance professional technical guidance in field of expertise to the organization. Support includes but is not limited to the following activities: Defines and manages validation strategy for Computer Systems/Equipment, considering operational and regulatory requirements. Writes Computer System Validation and equipment qualification required documents as per applicable procedures. Defines/writes User & Functional Specifications and Risk Assessment documents. Supports audit process, as required. Design test procedures and acceptance criteria with the purpose of demonstrating compliance with equipment, user and regulatory requirements while conducting Factory Acceptance Test (FAT), Installation Qualification (IQ) and Operation Qualifications (OQ) processes. Executes and collects data while conducting FAT, IQ and OQ processes. Writes related documentation. Writes Standard Operation Procedures (SOP) for the validated system/equipment. Provide training as required. Performs documents verifications and transcription checks. Manages multiples projects with multiple priorities, taking actions to meet organizational expectations. Prepares and presents business cases for capital projects. Prepares and owns change controls related to assigned projects. Uses project management techniques to identify possible roadblocks and anticipate them. Prepares/maintains own projects schedule or for those assigned to oversee. Process controls system design and specifications. Support and conducts technical investigations. Provides technical perspective during internal and external audits, regulatory inspection and due diligence. Provides technical support during process and lab equipment/system troubleshooting and process control troubleshooting. Recommends measures to improve manufacturing processes, equipment performance and quality of product Provide technical consultation services to other plant areas such as Manufacturing, Bulk Packaging, Labs, New Products, Process Support and Utilities. Backup and restore process of systems software. Access control management Support projects related to work and troubleshooting in day-to-day operations. Performs and coordinates process controls maintenance as established on the applicable procedures and as required by the GMP regulations. Qualifications Bachelor in Scence Bilingual (Spanish/English) Computer Literacy Experience in the applicable following technologies: mechanics, hydraulics, pneumatic, electronics, PLCs, SCADA, test equipment, HVAC, formulation, compression, and coating. Knowledge or experience in operation, maintenance and troubleshooting of plant utilities, solid dose manufacturing and packaging equipment/systems and its computer/control systems. Programming knowledge on Ladder logic, Wonderware, Visual Basic. Working knowledge in ladder logic coding structure. High degree of PC and PLC technical skills (hardware and software). PLC programming skills and working knowledge on AB and Siemens PLCs and the software platforms identified in the section above. Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The Senior Technology Professional will coordinate and conduct Computer System Validation and qualification for required systems and equipment, ensuring compliance with procedures and guidelines. They will also provide technical support for manufacturing and lab equipment/systems and lead projects related to process controls.