5830- Labvantage LIMS Validation Specialist / Senior Validation Engineer 2
Job Description
Job Description
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
Job Overview:
We are seeking an experienced LabVantage LIMS Validation Specialist to lead the documentation and validation of a LabVantage LIMS project in a GxP regulated environment. The ideal candidate will have hands-on experience in system implementation/configuration, writing design specifications, and validation processes. Experience with ValGenesis for validation management is a plus.
Labvantage LIMS Validation Specialist Responsibilities:
- Lead the end-to-end documentation and validation processes of LabVantage LIMS in a GxP-regulated laboratory environment
- CSV/Lab Systems Qualification document/deliverable authoring
- Author and maintain Design Specifications , ensuring alignment with regulatory and business requirements
- Develop and execute validation protocols (IQ/OQ/PQ) and ensure compliance with GMP, GLP, and GCP standards
- Collaborate with cross-functional teams including IT, Quality Assurance, and Lab personnel
- Manage system configuration, testing, and troubleshooting
- SOP modification and authoring
- Spreadsheet validation
- Prepare comprehensive project documentation including URS, FRS, Configuration Specs, and Test Scripts
- Utilize ValGenesis for validation lifecycle management, ensuring an efficient and compliant validation process
- Provide training and support to end users
Requirements:
- 5+ years of experience validating LabVantage LIMS in a GxP environment
- Strong expertise in CSV/Lab Systems Qualification document/deliverable authoring
- Experience with ValGenesis or similar validation lifecycle management tools
- Solid understanding of GxP, 21 CFR Part 11, and Data Integrity compliance requirements
- Ability to work independently and lead implementation projects with minimal oversight
- Strong problem-solving skills and the ability to troubleshoot technical issues
- Excellent communication and collaboration skills
Additional Details:
- On-site presence in Somerset, NJ, is preferred ; however, remote candidates will be considered if needed
- Immediate start date with commitment through the end of 2025, with the potential to extend through Q1 2026
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range
$80,465—$122,600 USD
Benefits
Why Choose Verista?
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com
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