Systems Engineer III - Aequor Technologies LLC
Waltham, MA 02451
About the Job
GxP IT and CS Engineer
The GxP IT and computer Systems Engineer is responsible for implementation, support, and troubleshooting of GxP computer systems, facilitating and working closely with System Owners(s), Validation and QAV teams to assure data integrity and security compliance.
Main Responsibilities:
" Oversee the installation activities for each instrument type, including guiding the Non-GxP IT team in setting up computer workstations, ensuring data security and permissions, configuring software, and more according to the *** Standards for GxP Computerized Systems.
" Collaborate with business owners and validation to create and edit key SDLC deliverables, including Change Control Records, User Requirements Specifications, Configuration Specifications, Risk Assessments, and IQ, OQ, PQ Test Cases.
" Troubleshoot user access, security, and software issues for GxP Computer Systems.
" Technical support for PCs running GxP instrument software.
" Conduct Backups of local GxP lab systems.
" Conduct Periodic Reviews: User Accounts, Backups & Audit Trail and perform Corrective actions identified in Periodic reviews.
" Create Decommissioning/Data Archiving plan and procedures and support decommissioning/data Migration activities in GxP CS Validation Life Cycle.
" Act as technical administrator for automated systems, software application, including managing accounts change/patch management and any associated maintenance.
" Implement and deploy data integrity risk management and remediation plans.
" Assist with and provide input as SME and Technical system owner (TSO) for the other documents in validation process, such as user and/or functional requirements, risk assessment, operational qualification related to software functions, etc.
" Contacting vendors as needed for troubleshooting and resolving issues.
" Creation/modification of user accounts in applications as needed following administration procedures.
" Support in developing, executing, reviewing and approving CSV deliverables according to regulatory authorities and *** Standards for GxP computerized systems to support R&D activities.
" Participate in GxP CS Quality Third Part Audits and represent GxP IT in *** Global Quality Audits Waltham Site.
" Data integrity, compliance, and inspection readiness lead for site GxP computer systems platforms.
Description of Duties:
" Provide IT support for GxP systems owners/users.
" Lead GxP IT and Computer systems' implementations collaborating with Business Process Owners (GxP Labs and Manufacturing), Vendors and QA Validation.
" Generate and maintain GxP Computer System Standard Operating Procedures (SOPs) in alignment with *** Global Standards and perform Gap Assessment for Waltham site.
" Participate in GxP CSV activities including execution of IQ/OQ/PQ and creation of test scripts, as required.
" Support in performing the periodic reviews of GxP Computerized systems.
" Develop and implement data integrity strategies including data protection, backups and disaster recovery.
" Maintain systems under change control and assist with impact assessments and the necessary documentation for changes.
" Collaborate with the corporate IT team to support infrastructure needs for GxP Computerized systems.
" Demonstrate excellent interpersonal skills, including the ability to resolve conflicts and the ability to interact with people of a wide variety of backgrounds, levels of responsibility and education levels.
" Provide guidance and set standards in producing quality documentation for GxP computerized Systems, serving as liaison between Digital IT and local Business process owners and QA Validation functions.
" Support in process improvement efforts of computer system policies, procedures, and computer system validation processes.
" Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
" Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
Required Qualifications:
" Bachelor's degree in Engineering, Computer Science, Information Technology Systems or related field.
" A minimum of 4 years' experience within the biotech or pharmaceutical industry.
" A minimum of 4 years hands on technical experience supporting IT systems including Windows Server, Active Directory, LDAP, SQL databases, terminal servers, data backup utilities, etc.
" Experience with lab systems including HPLC, UPLC, Mass Spec, UV-Vis and FTIR from different manufacturers (Thermo Fisher, Agilent, Novasep, Gilson, etc.).
" Good understanding of computer systems management in cGMP operations.
" An understanding of GAMP 5, 21 CFR Part 11, Annex 11, and other industry best practices is required.
Preferred Knowledge and Experience:
" eQMS (Veeva, etc.)
" Lab Software (Thermo, Agilent, Waters, etc.)
" Backup and Recovery Tools (Acronis, etc.)
" Windows Server
" Active Directory
" SQL
" Terminal Servers
" OS Patching
The GxP IT and computer Systems Engineer is responsible for implementation, support, and troubleshooting of GxP computer systems, facilitating and working closely with System Owners(s), Validation and QAV teams to assure data integrity and security compliance.
Main Responsibilities:
" Oversee the installation activities for each instrument type, including guiding the Non-GxP IT team in setting up computer workstations, ensuring data security and permissions, configuring software, and more according to the *** Standards for GxP Computerized Systems.
" Collaborate with business owners and validation to create and edit key SDLC deliverables, including Change Control Records, User Requirements Specifications, Configuration Specifications, Risk Assessments, and IQ, OQ, PQ Test Cases.
" Troubleshoot user access, security, and software issues for GxP Computer Systems.
" Technical support for PCs running GxP instrument software.
" Conduct Backups of local GxP lab systems.
" Conduct Periodic Reviews: User Accounts, Backups & Audit Trail and perform Corrective actions identified in Periodic reviews.
" Create Decommissioning/Data Archiving plan and procedures and support decommissioning/data Migration activities in GxP CS Validation Life Cycle.
" Act as technical administrator for automated systems, software application, including managing accounts change/patch management and any associated maintenance.
" Implement and deploy data integrity risk management and remediation plans.
" Assist with and provide input as SME and Technical system owner (TSO) for the other documents in validation process, such as user and/or functional requirements, risk assessment, operational qualification related to software functions, etc.
" Contacting vendors as needed for troubleshooting and resolving issues.
" Creation/modification of user accounts in applications as needed following administration procedures.
" Support in developing, executing, reviewing and approving CSV deliverables according to regulatory authorities and *** Standards for GxP computerized systems to support R&D activities.
" Participate in GxP CS Quality Third Part Audits and represent GxP IT in *** Global Quality Audits Waltham Site.
" Data integrity, compliance, and inspection readiness lead for site GxP computer systems platforms.
Description of Duties:
" Provide IT support for GxP systems owners/users.
" Lead GxP IT and Computer systems' implementations collaborating with Business Process Owners (GxP Labs and Manufacturing), Vendors and QA Validation.
" Generate and maintain GxP Computer System Standard Operating Procedures (SOPs) in alignment with *** Global Standards and perform Gap Assessment for Waltham site.
" Participate in GxP CSV activities including execution of IQ/OQ/PQ and creation of test scripts, as required.
" Support in performing the periodic reviews of GxP Computerized systems.
" Develop and implement data integrity strategies including data protection, backups and disaster recovery.
" Maintain systems under change control and assist with impact assessments and the necessary documentation for changes.
" Collaborate with the corporate IT team to support infrastructure needs for GxP Computerized systems.
" Demonstrate excellent interpersonal skills, including the ability to resolve conflicts and the ability to interact with people of a wide variety of backgrounds, levels of responsibility and education levels.
" Provide guidance and set standards in producing quality documentation for GxP computerized Systems, serving as liaison between Digital IT and local Business process owners and QA Validation functions.
" Support in process improvement efforts of computer system policies, procedures, and computer system validation processes.
" Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
" Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
Required Qualifications:
" Bachelor's degree in Engineering, Computer Science, Information Technology Systems or related field.
" A minimum of 4 years' experience within the biotech or pharmaceutical industry.
" A minimum of 4 years hands on technical experience supporting IT systems including Windows Server, Active Directory, LDAP, SQL databases, terminal servers, data backup utilities, etc.
" Experience with lab systems including HPLC, UPLC, Mass Spec, UV-Vis and FTIR from different manufacturers (Thermo Fisher, Agilent, Novasep, Gilson, etc.).
" Good understanding of computer systems management in cGMP operations.
" An understanding of GAMP 5, 21 CFR Part 11, Annex 11, and other industry best practices is required.
Preferred Knowledge and Experience:
" eQMS (Veeva, etc.)
" Lab Software (Thermo, Agilent, Waters, etc.)
" Backup and Recovery Tools (Acronis, etc.)
" Windows Server
" Active Directory
" SQL
" Terminal Servers
" OS Patching
Source : Aequor Technologies LLC