Role Description:      

·                  As a Lab IT & Automation IT Administrator , you are responsible for providing hands-on end user support, administration and issue resolution for GxP controlled laboratory & shopfloor equipment, servers, desktops and software packages.

•                  Manage day-to-day client communication and ongoing relationships as it relates to current, new and upcoming projects

·                  Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.

·                  Execute routine system administration and maintenance activities as required.

·                  Ensure proper user management process is adhered to for all computerized systems

·                  Administer lab system access requests

·                  Ensures systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annex 11 and all Data Integrity standards and guidelines. Ensure applicable standards and specifications are adhered to.

·                  Work closely with CSV Lead, System Integrator and Site IT Team.

·                  Work with operational readiness team and operations to ensure acceptable turnover.

·                  Provide support during internal and agency inspections.

·                  Provide subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs

·                  Advanced knowledge of system vulnerabilities and security issues.

·                  Monitor the system daily and respond immediately to security or usability concerns.

·                  Create and verify backups of data

·                  Respond to and resolve help desk requests

Qualifications & Education:

·                  Bachelor’s Degree or Higher in a technical discipline 

·                  5+ years of professional experience in the digital space  

·                  Excellent communication skills (written and oral).

·                  Ability to multi-task and handle tasks with competing priorities effectively.

·                  Experience identifying operational issues and recommending and implementing strategies to resolve problems 

Desired Qualifications:

·                  At least 3 years of experience working in a similar position within a GxP regulated environment

•                  Knowledge of shop floor automation technology (ISA 95 level 2/3)

•                  Experience in working with PLC/SCADA systems, PCS7 etc.

·                  Familiarity of various COTS applications used in pharma industry such as LabX, Acronis, Kneat, Empower, LIMS, Tiamo, FTIR, qPCR etc.. will be a plus

·                  You have strong analytical skills and an aptitude for decision-making 

·                  You show resilience when faced with challenges

·                  You believe in continuous learning and growth 

 Role Description:      

·                  As a Lab IT & Automation IT Administrator , you are responsible for providing hands-on end user support, administration and issue resolution for GxP controlled laboratory & shopfloor equipment, servers, desktops and software packages.

•                  Manage day-to-day client communication and ongoing relationships as it relates to current, new and upcoming projects

·                  Troubleshoot and resolve complex laboratory technical issues involving software, OS, hardware, network, or scientific equipment setup/interfaces.

·                  Execute routine system administration and maintenance activities as required.

·                  Ensure proper user management process is adhered to for all computerized systems

·                  Administer lab system access requests

·                  Ensures systems are in compliance with 21 CFR Part 11 Electronic Records and Electronic Signature requirements, as well as requirements from EU Annex 11 and all Data Integrity standards and guidelines. Ensure applicable standards and specifications are adhered to.

·                  Work closely with CSV Lead, System Integrator and Site IT Team.

·                  Work with operational readiness team and operations to ensure acceptable turnover.

·                  Provide support during internal and agency inspections.

·                  Provide subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs

·                  Advanced knowledge of system vulnerabilities and security issues.

·                  Monitor the system daily and respond immediately to security or usability concerns.

·                  Create and verify backups of data

·                  Respond to and resolve help desk requests

Qualifications & Education:

·                  Bachelor’s Degree or Higher in a technical discipline 

·                  5+ years of professional experience in the digital space  

·                  Excellent communication skills (written and oral).

·                  Ability to multi-task and handle tasks with competing priorities effectively.

·                  Experience identifying operational issues and recommending and implementing strategies to resolve problems 

Desired Qualifications:

·                  At least 3 years of experience working in a similar position within a GxP regulated environment

•                  Knowledge of shop floor automation technology (ISA 95 level 2/3)

•                  Experience in working with PLC/SCADA systems, PCS7 etc.

·                  Familiarity of various COTS applications used in pharma industry such as LabX, Acronis, Kneat, Empower, LIMS, Tiamo, FTIR, qPCR etc.. will be a plus

·                  You have strong analytical skills and an aptitude for decision-making 

·                  You show resilience when faced with challenges

·                  You believe in continuous learning and growth