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In Lims Validation Jobs in Ohio (NOW HIRING)

BrickRed Systems

MES Site Coordinator

Cincinnati, OH · On-site

LIMS Integration * Barcode Systems * Label Printing * Shopfloor Devices * Validation & CSV * Life ... Experience working in manufacturing environments Key Responsibilities * Act as the primary site ...

United Airlines

Veeva Expert

Cincinnati, OH · On-site

$68K - $150K/yr

At Capgemini Engineering, the world leader in engineering services, we bring together a global team ... Compliance & Validation * Ensure compliance with GxP, GMP, FDA regulations, 21 CFR Part 11, and ...

Peak Recruiter

Embryologist

Beachwood, OH

... in the EMR/LIMS. * Execute all aspects of daily embryology workflow with precision and adherence to protocols. * Conduct quality control, calibration, and validation of laboratory equipment and ...

Peak Recruiter

Embryologist

Beachwood, OH

... in the EMR/LIMS. * Execute all aspects of daily embryology workflow with precision and adherence to protocols. * Conduct quality control, calibration, and validation of laboratory equipment and ...

United Airlines

Veeva Expert

Cincinnati, OH · On-site

$68K - $150K/yr

Location Details Location is onsite in Cincinnati OH About the Job You Are Considering We are ... Compliance & Validation * Ensure compliance with GxP, GMP, FDA regulations, 21 CFR Part 11, and ...

Peak Recruiter

Embryologist

Beachwood, OH · On-site

... in the EMR/LIMS. * Execute all aspects of daily embryology workflow with precision and adherence to protocols. * Conduct quality control, calibration, and validation of laboratory equipment and ...

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Showing results 21-40

All JobsIn Lims Validation JobsIn Lims Validation Jobs in Ohio

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 is an In Lims Validation specialist job description?

An In Lims Validation specialist is responsible for ensuring that laboratory information management systems (LIMS) are properly validated and compliant with industry standards. They develop validation protocols, execute testing, document results, and collaborate with quality assurance teams to maintain data integrity and system functionality. Proficiency in validation processes, regulatory requirements, and LIMS software is essential for this role.
What are popular job titles related to In Lims Validation jobs in Ohio? For In Lims Validation jobs in Ohio, the most frequently searched job titles are:
What job categories do people searching In Lims Validation jobs in Ohio look for? The top searched job categories for In Lims Validation jobs in Ohio are:
What cities in Ohio are hiring for In Lims Validation jobs? Cities in Ohio with the most In Lims Validation job openings:
In Lims Validation jobs near you

Stability Administrator

Hikma Pharmaceuticals PLC

Bedford, OH • On-site

$44K - $74K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 11 days ago

Hikma Pharmaceuticals rating

8.0

Company rating: 8.0 out of 10

Based on 30 frontline employees who took The Breakroom Quiz

43rd of 86 rated pharmaceutical

Job description

Job Title: Stability Administrator
Location: Bedford, Ohio
Job Type: Full-Time
About Us:
As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.
Description:
We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Stability Administrator to join our team. In this role, you will be responsible for coordinating and maintaining stability programs supporting oral and sterile injectable products. This role ensures that all stability studies are executed in compliance with ICH guidelines, FDA regulations, and cGMP requirements, supporting Hikma's commitment to delivering high-quality, affordable medicines globally.
The position plays a key role in sample lifecycle management, data integrity, and inspection readiness, particularly within regulated, FDA-inspected manufacturing environments.
Key Responsibilities:
Stability Program Coordination
  • Manage stability programs in accordance with ICH Q1A(R2) and Hikma procedures.
  • Maintain stability schedules for commercial products, validation batches, and stability commitments.
  • Coordinate sample pulls and testing timelines (e.g., 0, 3, 6, 12, 24, 36 months).
  • Ensure alignment with regulatory commitments (ANDA/NDA submissions).

Sample Management & Stability Chambers
  • Oversee receiving, labeling, storage, and tracking of stability samples.
  • Manage stability chambers under controlled conditions:
    • Long-term, intermediate, and accelerated conditions
  • Monitor chamber performance (temperature/humidity) and escalate excursions.
  • Maintain inventory and traceability of samples in compliance with data integrity standards.

Documentation & Data Integrity
  • Maintain stability protocols, reports, and logs in compliance with:
    • cGMP (21 CFR Part 210/211)
    • ICH guidelines
  • Ensure adherence to ALCOA+ principles for all stability data.
  • Enter and verify data in electronic systems (e.g., LIMS, TrackWise, Veeva).
  • Support preparation of stability reports for regulatory submissions and annual product reviews (APR/PQR).

Compliance & Inspection Readiness
  • Ensure audit readiness for FDA and international inspections.
  • Support internal/external audits by providing accurate and complete documentation.
  • Ensure stability program compliance with global regulatory bodies (FDA, EMA, MHRA).

Deviation, CAPA & Investigations
  • Document and track stability-related deviations (e.g., missed pulls, chamber excursions).
  • Assist with investigations and root cause analysis.
  • Support implementation and closure of CAPA actions in collaboration with QA.

Cross-functional Collaboration
  • Partner with:
    • QC Laboratories (testing coordination)
    • QA (compliance oversight)
    • Regulatory Affairs (submission support)
    • Manufacturing (batch tracking)
  • Support new product launches, technology transfers, and lifecycle management.

Qualifications & Experience
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
Education
  • Bachelor's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline

Experience
  • 2-5+ years of experience in stability, QC, or GMP documentation in pharmaceutical industry
  • Experience in FDA-regulated environments required
  • Experience with injectable or sterile products preferred

Technical Skills
  • Strong understanding of:
    • ICH stability requirements (Q1A, Q1B)
    • cGMP documentation practices
  • Experience with:
    • Stability tracking systems, LIMS
    • Temperature/humidity monitoring systems
  • Knowledge of data integrity and audit readiness principles

Compensation:
Base Salary: $44,900.00 to $74,950.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.
What We Offer*:
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma's Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
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