Senior Support Engineer

Job Summary

Role Description:

Lab IT Administrator role whose primary responsibility will be to work with Lab COE and local site DMO team to provide end to end support for the Business users & Stakeholders, Coordinate with Site for technical topics, Co-ordinate with Support team, etc.,

Role Functions (Functions include, but are not limited to, the following):

• As a Lab IT Administrator , you are responsible for providing hands-on end user support, administration and issue resolution for GxP controlled laboratory equipment, servers, desktops and software packages.
• 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
• Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
• Assist systems users with defining, authoring, and documenting system use in user, admin, and maintenance SOPs
• 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
• Take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
• 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
• Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
• Understanding of Data Integrity concepts is required
• Excellent communication and written skills required

Key Responsibilities

Role Description:

Lab IT Administrator role whose primary responsibility will be to work with Lab COE and local site DMO team to provide end to end support for the Business users & Stakeholders, Coordinate with Site for technical topics, Co-ordinate with Support team, etc.,

Role Functions (Functions include, but are not limited to, the following):

• As a Lab IT Administrator , you are responsible for providing hands-on end user support, administration and issue resolution for GxP controlled laboratory equipment, servers, desktops and software packages.
• 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
• Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
• Assist systems users with defining, authoring, and documenting system use in user, admin, and maintenance SOPs
• 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
• Take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
• 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
• Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
• Understanding of Data Integrity concepts is required
• Excellent communication and written skills required

Skill Requirements

Other Requirements