Pinnaql
Overview
Pinnaql
is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness. System Administrator, Laboratory Systems
is a role at a specialty pharmaceutical manufacturer to support sites in Fort Worth, TX and Marietta, GA. Base pay range $95,000.00/yr - $125,000.00/yr Location: Fort Worth, TX; travel to Marietta, GA up to 50%. Start: 2 days ago (posting context is omitted from this refined description). Position overview
The System Administrator, Laboratory Systems is a member of the corporate quality group responsible for implementing and maintaining laboratory equipment to ensure quality and regulatory requirements are achieved (GAMP 5, cGMP, FDA 21 CFR Part 11). The System Administrator will assist with system and instrument validation/qualification. Duties and responsibilities
Based in Fort Worth, TX – travel to Marietta, GA up to 50% Serve as an application-level or system-level administrator for laboratory equipment. Responsible for managing the equipment lifecycle including delivery, integration, modification, and maintenance. Lead the planning, execution, and documentation of laboratory equipment validation activities according to regulatory requirements (GAMP 5, cGMP, FDA 21 CFR Part 11) and corporate policies by developing and maintaining validation documentation including GxP Assessments, Change Controls, Validation Plans, Risk Assessments, Requirements, Design/Functional Specifications, IQ/OQ/PQ Protocols, Trace Matrices, and other documentation required for implementing and maintaining laboratory equipment and equipment software. Coordinate vendor installations and incorporate vendor validation documentation into the validation process. Perform periodic assessments of previously validated laboratory equipment, highlighting potential compliance risks and acting proactively to resolve issues. Evaluate and assign appropriate user roles and privileges for data integrity (where applicable) for laboratory equipment. Author laboratory equipment administration and security procedures. Provide guidance on CSV best practices and ensure adherence to internal policies and industry standards. Collaborate with IT, Quality Assurance, and other stakeholders to ensure alignment with project timelines and objectives. Develop and perform any required remediation effort and associated CAPA plan. Support quality improvements related to regulatory agency observations and recommendations. Consult or contribute to other validation projects as needed and time allowing. Perform other duties as required. Experience and qualifications
Bachelor's degree in Technology or Engineering discipline A minimum of 5 years\' experience in laboratory systems in the pharmaceutical or related industry Strong GMP compliance knowledge, including GAMP 5, 21 CFR Part 11, EU Annex 11, among others Knowledge of GxP Computer System Validation (CSV) activities and testing practices within the pharmaceutical industry Ability to manage multiple projects simultaneously while performing day-to-day activities Ability to present technical information to management, employees, and other departments Self-motivated team player with exceptional organization, follow-through, time management, and communication skills Excellent ability to write, review, edit, and approve technical documentation Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management Preferred experience / skills
Hands-on working knowledge in Laboratory Information Management Systems (LIMS) and Quality Management Systems (QMS) Equal opportunity statement
Pinnaql is an equal opportunity employer.
All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. Seniority level
Entry level Employment type
Full-time Job function
Manufacturing, Quality Assurance, and Engineering Industries
Pharmaceutical Manufacturing
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Pinnaql
is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness. System Administrator, Laboratory Systems
is a role at a specialty pharmaceutical manufacturer to support sites in Fort Worth, TX and Marietta, GA. Base pay range $95,000.00/yr - $125,000.00/yr Location: Fort Worth, TX; travel to Marietta, GA up to 50%. Start: 2 days ago (posting context is omitted from this refined description). Position overview
The System Administrator, Laboratory Systems is a member of the corporate quality group responsible for implementing and maintaining laboratory equipment to ensure quality and regulatory requirements are achieved (GAMP 5, cGMP, FDA 21 CFR Part 11). The System Administrator will assist with system and instrument validation/qualification. Duties and responsibilities
Based in Fort Worth, TX – travel to Marietta, GA up to 50% Serve as an application-level or system-level administrator for laboratory equipment. Responsible for managing the equipment lifecycle including delivery, integration, modification, and maintenance. Lead the planning, execution, and documentation of laboratory equipment validation activities according to regulatory requirements (GAMP 5, cGMP, FDA 21 CFR Part 11) and corporate policies by developing and maintaining validation documentation including GxP Assessments, Change Controls, Validation Plans, Risk Assessments, Requirements, Design/Functional Specifications, IQ/OQ/PQ Protocols, Trace Matrices, and other documentation required for implementing and maintaining laboratory equipment and equipment software. Coordinate vendor installations and incorporate vendor validation documentation into the validation process. Perform periodic assessments of previously validated laboratory equipment, highlighting potential compliance risks and acting proactively to resolve issues. Evaluate and assign appropriate user roles and privileges for data integrity (where applicable) for laboratory equipment. Author laboratory equipment administration and security procedures. Provide guidance on CSV best practices and ensure adherence to internal policies and industry standards. Collaborate with IT, Quality Assurance, and other stakeholders to ensure alignment with project timelines and objectives. Develop and perform any required remediation effort and associated CAPA plan. Support quality improvements related to regulatory agency observations and recommendations. Consult or contribute to other validation projects as needed and time allowing. Perform other duties as required. Experience and qualifications
Bachelor's degree in Technology or Engineering discipline A minimum of 5 years\' experience in laboratory systems in the pharmaceutical or related industry Strong GMP compliance knowledge, including GAMP 5, 21 CFR Part 11, EU Annex 11, among others Knowledge of GxP Computer System Validation (CSV) activities and testing practices within the pharmaceutical industry Ability to manage multiple projects simultaneously while performing day-to-day activities Ability to present technical information to management, employees, and other departments Self-motivated team player with exceptional organization, follow-through, time management, and communication skills Excellent ability to write, review, edit, and approve technical documentation Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management Preferred experience / skills
Hands-on working knowledge in Laboratory Information Management Systems (LIMS) and Quality Management Systems (QMS) Equal opportunity statement
Pinnaql is an equal opportunity employer.
All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. Seniority level
Entry level Employment type
Full-time Job function
Manufacturing, Quality Assurance, and Engineering Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr