... and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business ... Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit ...
... and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business ... Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit ...
... and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business ... Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit ...
... and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business ... Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit ...
... and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business ... Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit ...
... and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business ... Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit ...
Data Management Specialist
$59K - $87K/yr
... in a regulated environment KNOWLEDGE, SKILLS AND ABILITIES: • Knowledge of administrating a LIMS ... Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.
Data Management Specialist
$59K - $87K/yr
... in a regulated environment KNOWLEDGE, SKILLS AND ABILITIES: • Knowledge of administrating a LIMS ... Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.
Data Management Specialist
Gaithersburg, MD · On-site
$59K - $87K/yr
... in a regulated environment KNOWLEDGE, SKILLS AND ABILITIES: • Knowledge of administrating a LIMS ... Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates. Equal ...
Data Management Specialist
Gaithersburg, MD · On-site
$59K - $87K/yr
... in a regulated environment KNOWLEDGE, SKILLS AND ABILITIES: • Knowledge of administrating a LIMS ... Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates. Equal ...
Salesforce Architect
Leesburg, VA · On-site
$69.75 - $86.50/hr
Experience in life sciences, GxP, LIMS, or other regulated operational environments is highly ... Ability to guide data migration and data-quality strategy, including mapping, cleansing, validation ...
Salesforce Architect
Leesburg, VA · On-site
$69.75 - $86.50/hr
Experience in life sciences, GxP, LIMS, or other regulated operational environments is highly ... Ability to guide data migration and data-quality strategy, including mapping, cleansing, validation ...
Participate in contingency planning, system testing events, validation activities, and recovery ... or LIMS in a regulated, operational, laboratory, or secure environment; familiarity with ...
Participate in contingency planning, system testing events, validation activities, and recovery ... or LIMS in a regulated, operational, laboratory, or secure environment; familiarity with ...
... validate improvements, and support acceptance testing for STARLIMS. The analyst will lead ... Experience with STARLIMS, LabVantage, LABWORKS, or equivalent LIMS platforms is strongly preferred.
Quick apply
... validate improvements, and support acceptance testing for STARLIMS. The analyst will lead ... Experience with STARLIMS, LabVantage, LABWORKS, or equivalent LIMS platforms is strongly preferred.
LIMS, Empower, and MassLynx). * Works with the CSV and IT teams to support the generation of ... Ensures GxP lab systems remain in a validated state. Supervisory Responsibilities: * N/A. Knowledge ...
LIMS, Empower, and MassLynx). * Works with the CSV and IT teams to support the generation of ... Ensures GxP lab systems remain in a validated state. Supervisory Responsibilities: * N/A. Knowledge ...
Study Coordinator
Gaithersburg, MD · On-site
$60K - $75K/yr
... in drafting Analytical Plans and to support all phases of the business (Transfer, Validation and ... Functional knowledge of Watson LIMS is a plus. * Extremely strong competence using Microsoft Word ...
Study Coordinator
Gaithersburg, MD · On-site
$60K - $75K/yr
... in drafting Analytical Plans and to support all phases of the business (Transfer, Validation and ... Functional knowledge of Watson LIMS is a plus. * Extremely strong competence using Microsoft Word ...
Study Coordinator
Gaithersburg, MD · Hybrid
$60K - $75K/yr
... in drafting Analytical Plans and to support all phases of the business (Transfer, Validation and ... Functional knowledge of Watson LIMS is a plus. * Extremely strong competence using Microsoft Word ...
Study Coordinator
Gaithersburg, MD · Hybrid
$60K - $75K/yr
... in drafting Analytical Plans and to support all phases of the business (Transfer, Validation and ... Functional knowledge of Watson LIMS is a plus. * Extremely strong competence using Microsoft Word ...
Associate Research Scientist
$75K - $100K/yr
PDS works with customers to develop new methods, validate existing methods, as well as performing ... in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS ...
Associate Research Scientist
$75K - $100K/yr
PDS works with customers to develop new methods, validate existing methods, as well as performing ... in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS ...
Associate Research Scientist
Gaithersburg, MD · On-site
$75K - $100K/yr
PDS works with customers to develop new methods, validate existing methods, as well as performing ... in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS ...
Associate Research Scientist
Gaithersburg, MD · On-site
$75K - $100K/yr
PDS works with customers to develop new methods, validate existing methods, as well as performing ... in advanced computer applications including MS Word, Excel, statistical programs, and Watson LIMS ...
Bioprocessing Specialist
Gaithersburg, MD · On-site
$121K/yr
... LIMS). Experience refers to paid and unpaid experience, including volunteer work done through ... validate that the education requirement has been met. Unofficial transcripts will be accepted in ...
Bioprocessing Specialist
Gaithersburg, MD · On-site
$121K/yr
... LIMS). Experience refers to paid and unpaid experience, including volunteer work done through ... validate that the education requirement has been met. Unofficial transcripts will be accepted in ...
... LIMS). Experience refers to paid and unpaid experience, including volunteer work done through ... validate that the education requirement has been met. Unofficial transcripts will be accepted in ...
... LIMS). Experience refers to paid and unpaid experience, including volunteer work done through ... validate that the education requirement has been met. Unofficial transcripts will be accepted in ...
Experience in method development and validation of large molecules for cell and gene therapy ... Experience with LIMS system and data acquisition software. Performance requirements General
Experience in method development and validation of large molecules for cell and gene therapy ... Experience with LIMS system and data acquisition software. Performance requirements General
Bioanalysis Scientist I
Rockville, MD · On-site
Experience in method development and validation of large molecules for cell and gene therapy ... Experience with LIMS system and data acquisition software. Performance requirements General
Bioanalysis Scientist I
Rockville, MD · On-site
Experience in method development and validation of large molecules for cell and gene therapy ... Experience with LIMS system and data acquisition software. Performance requirements General
Associate Bioanalytical Scientist III
$65K - $75K/yr
... validation and sample analysis for large molecules in compliance with ICH M10 and regulatory ... Working knowledge of Watson™ Laboratory Information Management System (LIMS). * Experience ...
Associate Bioanalytical Scientist III
$65K - $75K/yr
... validation and sample analysis for large molecules in compliance with ICH M10 and regulatory ... Working knowledge of Watson™ Laboratory Information Management System (LIMS). * Experience ...
Associate Bioanalytical Scientist III
Germantown, MD · On-site
$65K - $75K/yr
... validation and sample analysis for large molecules in compliance with ICH M10 and regulatory ... Working knowledge of Watson™ Laboratory Information Management System (LIMS). * Experience ...
Associate Bioanalytical Scientist III
Germantown, MD · On-site
$65K - $75K/yr
... validation and sample analysis for large molecules in compliance with ICH M10 and regulatory ... Working knowledge of Watson™ Laboratory Information Management System (LIMS). * Experience ...
Sr. Manager, Quality
Harmans, MD · On-site
Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD-just minutes from BWI ... Support QC method transfer, qualification, validation, stability programs, and OOS/OOT ...
Sr. Manager, Quality
Harmans, MD · On-site
Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD-just minutes from BWI ... Support QC method transfer, qualification, validation, stability programs, and OOS/OOT ...
In Lims Validation information
What is the difference between In Lims Validation vs Laboratory Technician?
| Aspect | In Lims Validation | Laboratory Technician |
|---|---|---|
| Certifications | GMP, GLP, Validation certifications | Typically relevant certifications include Lab Technician or related training |
| Work Environment | Quality assurance, validation labs, regulated industries | Laboratories performing tests and experiments |
| Job Focus | Ensuring LIMS systems meet regulatory standards | Performing tests, recording data, maintaining lab equipment |
In Lims Validation professionals focus on validating Laboratory Information Management Systems to ensure compliance with industry standards, while Laboratory Technicians perform routine testing and data collection. Both roles are essential in regulated labs but differ in scope and responsibilities.
What are popular job titles related to In Lims Validation jobs in Washington? For In Lims Validation jobs in Washington, the most frequently searched job titles are:
What job categories do people searching In Lims Validation jobs in Washington look for? The top searched job categories for In Lims Validation jobs in Washington are:
What cities in Washington are hiring for In Lims Validation jobs? Cities in Washington with the most In Lims Validation job openings:
Full-time
Medical, Dental, Vision, Retirement, PTO
Re-posted 5 days ago
AstraZeneca rating
8.4
Based on 45 frontline employees who took The Breakroom Quiz
19th of 86 rated pharmaceutical
Job description
The Associate Director, Digital & Business Process Strategy leads the vision, roadmap, and value delivery of digital products that span PAS-X, Tulip (MES), data historians, and LIMS within AstraZeneca's manufacturing network. This role sits in the Digital & Business Process Strategy team and partners with Operations, Quality, Global IT, Data & AI, Supply Chain and Site teams to modernize data flows, improve Right-First-Time, and enable compliant, data-driven decision making from shop floor to enterprise. You will be based in Rockville, MD and report to the Senior Director of Digital & Business Process Strategy.
Key responsibilities
1. Product vision and roadmap
2. Stakeholder and value management
3. Delivery leadership
4. Compliance and validation
5. Data and analytics enablement
6. Operations readiness and lifecycle management
Required qualifications
Preferred qualifications
Key competencies
The annual base pay for this position ranges from $122K to $184K. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
16-Jul-2026
Closing Date
30-Jul-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Key responsibilities
1. Product vision and roadmap
- Define and socialize a compelling product vision linking MES (PAS-X, Tulip), Historian - CDZ, and LIMS capabilities to business outcomes (yield, cycle time, batch release, deviation reduction)
- Build and manage a multi-release roadmap, balancing global platforms with site needs, technical debt, and regulatory priorities.
- Maintain a prioritized, value-ranked backlog with clear acceptance criteria and Definition of Done
2. Stakeholder and value management
- Act as the voice of Operations, Quality, and QA/QP in product decisions; translate pain points into epics/features to deliver e2e business process maps and well-defined business requirements
- Quantify value through OKRs/KPIs (e.g., batch review time, exception rates, data availability SLAs) and track benefits realization.
3. Delivery leadership
- Lead agile squads (process SMEs, solution architects, data engineers, MES configuration, historians, LIMS specialists, validation) to deliver increments.
- Coordinate integration patterns between MES, historians, LIMS, ERP, data platforms, and analytics/AI products.
- Ensure robust data models, master data stewardship, and event/transaction standards supporting traceability across systems.
4. Compliance and validation
- Ensure products comply with GxP, 21 CFR Part 11/Annex 11, data integrity (ALCOA+), and site/enterprise validation requirements.
- Own validation strategy for changes (CSV/CSA), including risk assessments, test evidence, and audit readiness.
5. Data and analytics enablement
- Enable contextualized data capture and lineage from equipment and MES to historian and LIMS; expose governed data to analytics platforms.
- Partner with Data & AI teams on use cases such as real-time deviation detection, golden batch, CPV/Continued Process Verification, and eBR/eBRR optimization.
6. Operations readiness and lifecycle management
- Plan releases, cutovers, and change management across multiple sites; coordinate training and SOP updates.
- Own product performance, reliability, and cybersecurity posture; manage incidents, problem remediation, and continuous improvement.
- Manage vendor relationships (e.g., Körber, Factory Talk, PAS-X, Tulip, Historian and LIMS providers) and ensure contract deliverables align to roadmap.
Required qualifications
- Bachelor's degree in engineering, life sciences, computer science, or related field; advanced degree preferred.
- 8+ years in pharma/biotech or highly regulated manufacturing with hands-on exposure to at least two of the following: PAS-X (or equivalent MES), process data historians (e.g., PI/AVEVA, IP.21, Ignition), LIMS/ELN.
- 3+ years as a Product Owner or equivalent (product management, solution owner) delivering digital capabilities in GxP environments.
- Strong understanding of manufacturing and quality processes: recipe management, eBR, batch disposition, deviation/CAPA, CPV, stability, and sample lifecycle.
- Demonstrated experience integrating shop-floor systems with enterprise platforms (ERP, QMS) and data/analytics stacks; familiarity with ISA-95/ISA-88 models and data standards.
- Practical knowledge of CSV/CSA, GAMP 5, data integrity, and audit expectations.
Preferred qualifications
- Experience with PAS-X configuration and content management; knowledge of interface frameworks, EBR review workflows, and exception handling.
- Background in OT/IT convergence: OPC UA, MQTT, edge connectivity, time-series data modeling, and event streaming.
- Working knowledge of modern data platforms and analytics (e.g., cloud data lakes, time-series services, visualization, ML for manufacturing).
- Certification in Agile/Scrum (PSPO, CSPO) and/or product management; Lean Six Sigma or equivalent continuous improvement credentials.
- Experience operating across multi-site/global manufacturing organizations and managing vendor ecosystems.
Key competencies
- Business value orientation converts operational challenges into measurable outcomes and prioritizes accordingly.
- Systems thinking understands end-to-end data flows from equipment and MES to LIMS/quality and enterprise analytics.
- Stakeholder influence: builds alignment across Operations, Quality, IT, and site leadership.
- Decision making under compliance: balances speed with validation and data integrity requirements.
- Communication and change leadership; simplifies complex topics and drives adoption.
- Delivery excellence: strong backlog management, release planning, and risk mitigation.
The annual base pay for this position ranges from $122K to $184K. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
16-Jul-2026
Closing Date
30-Jul-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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