... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson) * Pharmaceutical or CRO experience
... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson) * Pharmaceutical or CRO experience
... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson) * Pharmaceutical or CRO experience
Quick apply
... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson) * Pharmaceutical or CRO experience
Lab & Quality Supervisor
Nekoosa, WI · On-site
Develop, validate, and maintain analytical methods and testing procedures. * Manage laboratory ... Bachelor's degree in Chemistry, Chemical Engineering, Inorganic Chemistry, or a related scientific ...
Lab & Quality Supervisor
Nekoosa, WI · On-site
Develop, validate, and maintain analytical methods and testing procedures. * Manage laboratory ... Bachelor's degree in Chemistry, Chemical Engineering, Inorganic Chemistry, or a related scientific ...
The LCMS Lead Scientist ensures that methods are validated, executed, and documented in alignment ... Familiarity with LIMS (Laboratory Information Management Systems) and related laboratory ...
Quick apply
The LCMS Lead Scientist ensures that methods are validated, executed, and documented in alignment ... Familiarity with LIMS (Laboratory Information Management Systems) and related laboratory ...
Analytical Chemist
Milwaukee, WI · On-site
Work with the Senior Analytical Chemist to qualify, develop, validate, and continuously improve the ... Proficient in the use of computers, standard office software and systems (e.g., LIMS, SAP), and the ...
Analytical Chemist
Milwaukee, WI · On-site
Work with the Senior Analytical Chemist to qualify, develop, validate, and continuously improve the ... Proficient in the use of computers, standard office software and systems (e.g., LIMS, SAP), and the ...
Analytical Chemist
Milwaukee, WI · On-site
Work with the Senior Analytical Chemist to qualify, develop, validate, and continuously improve the ... Proficient in the use of computers, standard office software and systems (e.g., LIMS, SAP), and the ...
Analytical Chemist
Milwaukee, WI · On-site
Work with the Senior Analytical Chemist to qualify, develop, validate, and continuously improve the ... Proficient in the use of computers, standard office software and systems (e.g., LIMS, SAP), and the ...
Meat Scientist
Fort Atkinson, WI · On-site
Manufacturer of Premium Meat Products in Fort Atkinson Jones Dairy Farm, a family owned ... Test, validate, and recommend changes to production processes to improve product quality, yield ...
Meat Scientist
Fort Atkinson, WI · On-site
Manufacturer of Premium Meat Products in Fort Atkinson Jones Dairy Farm, a family owned ... Test, validate, and recommend changes to production processes to improve product quality, yield ...
Jr .Net WPF Developer
Neenah, WI · On-site
The ideal candidate will bring strong expertise in WPF-based UI development, backend application ... to-end validation, integration testing, and issue resolution across device and application ...
Quick apply
Jr .Net WPF Developer
Neenah, WI · On-site
The ideal candidate will bring strong expertise in WPF-based UI development, backend application ... to-end validation, integration testing, and issue resolution across device and application ...
.NET Developer
Neenah, WI · On-site
$48.75 - $64.50/hr
If you thrive in device-connected, data-intensive environments and enjoy solving real-world ... Perform end-to-end validation, integration testing, and issue resolution across device and ...
Quick apply
.NET Developer
Neenah, WI · On-site
$48.75 - $64.50/hr
If you thrive in device-connected, data-intensive environments and enjoy solving real-world ... Perform end-to-end validation, integration testing, and issue resolution across device and ...
... method validation, process improvements, and implementation of new technologies or procedures ... LIMS) and Microsoft Office applications. PREFERRED Experience in a certified environmental or water ...
Quick apply
... method validation, process improvements, and implementation of new technologies or procedures ... LIMS) and Microsoft Office applications. PREFERRED Experience in a certified environmental or water ...
... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory ... Candidates must have current, valid authorization to work in the country where this role is located.
... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory ... Candidates must have current, valid authorization to work in the country where this role is located.
... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory ... Candidates must have current, valid authorization to work in the country where this role is located.
Quick apply
... LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory ... Candidates must have current, valid authorization to work in the country where this role is located.
Input and maintain laboratory test data in our LIMS lab management software. * Maintain laboratory ... Must have valid driver's license and clean driving record * The ability to lift 50-75+ pound
Input and maintain laboratory test data in our LIMS lab management software. * Maintain laboratory ... Must have valid driver's license and clean driving record * The ability to lift 50-75+ pound
... validation, process improvements, and implementation of new technologies or procedures. · Maintain ... systems (LIMS) and Microsoft Office applications. PREFERRED · Experience in a certified ...
Quick apply
... validation, process improvements, and implementation of new technologies or procedures. · Maintain ... systems (LIMS) and Microsoft Office applications. PREFERRED · Experience in a certified ...
Data Reviewer, Analytical Development
Verona, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Data Reviewer, Analytical Development
Verona, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Quality Control Supervisor
Madison, WI · On-site
$80K - $121K/yr
... in-process, intermediate, final products ... Other areas of responsibility may include, raw materials, method validation / qualification, and ...
Quality Control Supervisor
Madison, WI · On-site
$80K - $121K/yr
... in-process, intermediate, final products ... Other areas of responsibility may include, raw materials, method validation / qualification, and ...
Data Reviewer, Quality Control
Madison, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Quick apply
Data Reviewer, Quality Control
Madison, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Data Reviewer, Analytical Development
Madison, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Quick apply
Data Reviewer, Analytical Development
Madison, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Data Reviewer, Quality Control
Verona, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Data Reviewer, Quality Control
Verona, WI · On-site
$80K - $90K/yr
Familiarity with laboratory information systems, LIMS. * Strong verbal and written communication ... Candidates must have current, valid authorization to work in the country where this role is located.
Quality Control Supervisor
Madison, WI · On-site
$80K - $121K/yr
... in-process, intermediate, final products ... Other areas of responsibility may include, raw materials, method validation / qualification, and ...
Quality Control Supervisor
Madison, WI · On-site
$80K - $121K/yr
... in-process, intermediate, final products ... Other areas of responsibility may include, raw materials, method validation / qualification, and ...
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 Wisconsin? For In Lims Validation jobs in Wisconsin, the most frequently searched job titles are:
What job categories do people searching In Lims Validation jobs in Wisconsin look for? The top searched job categories for In Lims Validation jobs in Wisconsin are:
What cities in Wisconsin are hiring for In Lims Validation jobs? Cities in Wisconsin with the most In Lims Validation job openings:
Full-time
Posted 15 days ago
Job description
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA).
This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.
Responsibilities
Strategic Leadership & Governance
System Lifecycle Oversight
Validation Program Leadership
Project & Vendor Management
People & Organizational Development
Requirements
Preferred
Wisconsin pay range
$145,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Senior Manager GxP Systems & Validation provides strategic and operational leadership for GxP-regulated computerized systems across their full lifecycle. This role is accountable for governance, validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA).
This leader serves as a key partner to Manufacturing, Quality, CMC, CSA and Compliance, GLP Operations, and external vendors, driving scalable compliance frameworks while enabling business agility. The role combines system ownership and administration, validation project management, and organizational oversight to ensure enterprise-wide data integrity and computerized system compliance.
Responsibilities
Strategic Leadership & Governance
- Maintain governance frameworks for GxP computerized systems
- Define validation strategies aligned with GAMP 5 and CSA principles
- Support modernization initiatives (e.g., SaaS adoption, cloud validation, CSA transition)
- Serve as system owner and system administrator for critical GxP platforms
- Maintain validation and system lifecycle policies and standards
- Participates in continuous improvement of validation methodologies, templates, and risk-based approaches
- Provide compliance guidance to executive leadership and functional heads
System Lifecycle Oversight
- Oversee administration and compliant operation of GxP systems (Laboratory systems, LIMS, MES, EDMS, enterprise SaaS platforms)
- Ensure systems remain validated, secure, and audit-ready throughout implementation, upgrades, and decommissioning
- Approve system configurations, changes, and access governance frameworks
- Ensure robust data integrity controls in accordance with ALCOA+ principles
- Monitor system performance, audit trails, cybersecurity controls, and vendor compliance
Validation Program Leadership
- Lead enterprise validation initiatives across multiple concurrent projects
- Oversee development and approval of validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability, Summary Reports)
- Ensure appropriate application of risk-based validation and CSA methodologies
- Manage validation master planning and resource allocation
- Provide oversight of regression testing and revalidation strategies
- Ensure validation documentation supports global inspection readiness
- Act as SME during regulatory inspections and internal audits
- Oversee remediation efforts related to audit findings, deviations, and CAPAs
- Maintain awareness of evolving global regulatory expectations
Project & Vendor Management
- Lead cross-functional teams across CMC, Quality, IS&I, Manufacturing, Engineering, GLP Operations, and external partners
- Oversee third-party vendors and validation consultants
- Manage budgets, timelines, risks, and resource planning for validation programs
- Drive issue resolution and escalation management
- Ensure vendor deliverables meet compliance and quality standards
People & Organizational Development
- Lead, mentor, and develop validation and system administration staff
- Establish performance expectations and competency development plans
- Build scalable team capabilities to support business growth
Requirements
- Bachelor's degree in Life Sciences, Engineering, IT, or related discipline (advanced degree preferred)
- 8+ years of experience in GxP computerized systems and validation
- 3+ years in a leadership or program management role
- Deep expertise in CSV/CSA, GAMP 5, 21 CFR Part 11, Annex 11, and global data integrity requirements
- Demonstrated experience leading complex, enterprise-level system implementations
- Strong understanding of change control, deviation management, CAPA, and quality systems
- Proven ability to influence senior stakeholders and drive cross-functional alignment
Preferred
- PMP or equivalent project management certification
- GAMP, ITIL, or related compliance certification
- Experience leading CSA transformation initiatives
- Extensive experience related to administration, operation, and maintenance of Laboratory Information Management Systems (LIMS) Chromatography Data Systems, Spectrophotometry Systems, and ancillary/supporting laboratory systems in a GxP environment (Openlab, Cary UV systems, Watson)
- Pharmaceutical or CRO experience
- Prior regulatory inspection leadership experience
- Risk-based decision making
- Continuous improvement mindset
Wisconsin pay range
$145,000-$165,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
About Arrowhead Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Pasadena, CA, US
Year founded
1989