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In Lims Validation Jobs in Indiana (NOW HIRING)

Senior MES Engineer

Fishers, IN · On-site

$97K - $134K/yr

Provide technical support to Computer System Validation (CSV) activities, including MES ... LIMS systems in a regulated environment. Familiarity with analytics and reporting tools such as ...

Validation and Quality documentation (VMS) * Drive process standardization, optimization, and ... Bachelor's degree in Information Technology, Computer Science, Business Administration, Engineering ...

... ERP (SAP), LIMS, and shop-floor equipment (PLCs/SCADA), ensuring a reliable flow of data ... in a validated state, compliant with GxP and data integrity requirements. * Stakeholder ...

Indianapolis, IN #LI-Onsite About this role: In this people management role, the QC Chemistry ... Design and execute method transfers/qualifications/validations based on Regulatory guidelines and ...

... materials, in-process samples, finished product, and stability samples according to validated ... LIMS, JMP, Minitab, etc.) Additional Preferences: * Experience with Continuous Improvement, Six ...

Associate Director TSMS

Indianapolis, IN · On-site

$123K - $180K/yr

We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... validation, manufacturing support, process optimization, and lifecycle management of API products.

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In Lims Validation information

What is the difference between In Lims Validation vs Laboratory Technician?

AspectIn Lims ValidationLaboratory Technician
CertificationsGMP, GLP, Validation certificationsTypically relevant certifications include Lab Technician or related training
Work EnvironmentQuality assurance, validation labs, regulated industriesLaboratories performing tests and experiments
Job FocusEnsuring LIMS systems meet regulatory standardsPerforming 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 Indiana? For In Lims Validation jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching In Lims Validation jobs in Indiana look for? The top searched job categories for In Lims Validation jobs in Indiana are:
What cities in Indiana are hiring for In Lims Validation jobs? Cities in Indiana with the most In Lims Validation job openings:
Technician Analytical Lab (3949)

Technician Analytical Lab (3949)

NICE-PAK PRODUCTS LLC

Mooresville, IN

Full-time

Posted 8 days ago


Job description

ESSENTIAL FUNCTIONS AND BASIC DUTIES The Analytical Technician is responsible for accurate analysis of various chemical testing within the QC laboratories to ensure quality production of Nice-Pak products through use of Good Laboratory Practices and accurate documentation.

REPORTING & ANALYSIS:

  • Perform required analytical and chemical testing according to NPTMs, SOPs and WIs on raw materials, bulk liquids and finished products.
  • Perform non-routine chemical testing such as flush samples, sanitizer verifications and investigations.
  • Ensure that all results are accurately recorded in appropriate laboratory notebooks and another designated forms according to GLP’s.
  • Provide production and other plant areas technical expertise and analytical skills to facilitate problem solving and root cause analysis.
  • Order laboratory analytical supplies and monitor inventory levels.
  • Prepare standards and perform equipment calibrations and verifications.
  • Prepare / revise laboratory procedures (WIs, methods, SOPs, etc.) when required.
  • Review lab notebooks for 21CFR section 11 compliance.
  • All other duties as assigned.
  • The above is intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements.

TECHNICAL EXPERTISE:

  • Develop and perform validation studies when required.
  • Ensure compatibility between process capability and Finished Product Specifications.
  • Recommend equipment purchases and upgrades.
  • Support and perform method transfers and validations. Present lab results in monthly meetings.
  • Prepare / revise laboratory procedures (WIs, methods, SOPs, etc.) when required
  • Leadership: Handle special projects and assign them when required.
  • Furnish reports, as necessary, to the QA/QC manager, quality director, or designee.
  • Quality Planning and Continuous Improvement: Quality team problem solving and root cause analysis.
  • Assist with site cost savings goals as they relate to Quality.
  • Develop and implement short- and long-range goals and plans for continuous improvement.

PERFORMANCE MEASUREMENTS Safety Incidents Quality Compliance Performing to or below quality budget cost savings initiatives Service, teamwork, and communication Efficient analysis of analytical testing

LI-KM1

QUALIFICATIONS

EDUCATION/CERTIFICATION: Bachelor’s degree in chemistry or other related science degree.

REQUIRED KNOWLEDGE: Analytical methods and theories. Able to incorporate them into daily talks and problem solving. Able to follow test methodology accurately and precisely. Knowledge of computer software such as Microsoft Excel, Word, Access, LIMS, etc.

EXPERIENCE REQUIRED: At least one year experience as a technician in an Analytical laboratory environment, preferably in a manufacturing environment regulated by 21 CFR 210-211.

SKILLS/ABILITIES: Strong analytical skills with the ability to conduct root cause analysis for out of specification results. Good verbal and written communication skills demonstrated by the ability to generate technical reports. Ability to learn new test methods and minimize documentation errors in a cGMP environment.

#LI-KM1