LIMS Systems Validation

job summary :

The Professional Services Team is enlarging its workforce to offer a heightened range of Computer Systems Validation (CSV) services and solutions to meet the escalating demands of our customers.

As a pivotal member of the team, the LIMS CSV Specialist assumes responsibility for delivering CSV services. This may involve offering advisory consulting to clients on CSV, generating validation documentation and solutions that comply with pertinent regulatory standards, crafting or implementing test scripts, and fostering the ongoing development of the CSV function within the team.

Should you have any inquiries, please feel free to contact us without hesitation.

Matias Rodriguez

Account Manager

[email protected]

responsibilities :

This position entails developing solutions to address continually evolving regulatory guidelines. The ideal candidate is expected to maintain current knowledge academically, professionally, and technically, and commit to ongoing development as an integral aspect of the role.

Responsibilities : 75% :

75% :

• Provide validation consulting services and project management for proprietary software products in a customer-facing capacity throughout the product deployment lifecycle.
• Collaborate with customers during the presale stage to understand and clarify their requirements.
• Translate customer requirements into validation deliverables.
• Conduct gap analysis, formulate validation plans, and manage customer expectations.
• Produce high-quality validation documentation and execute test scripts as necessary.
• Offer expert validation consultancy to guide customers through the validation process.
• Lead cross-functional teams in developing validation deliverables.
• Analyze testing results and determine their acceptability.
• Review, edit, and approve validation documentation.
• Coordinate the completion and approval of all validation deliverables.
• This role may involve up to 15% travel.

15% :

• Engage in pre-sales and marketing activities, including discussions with sales, PSO, and / or customers.
• Identify opportunities for selling validation consulting services.
• Collaborate with sales to develop proposals for validation services delivery, including cost and effort estimation and scope definition.
• Work with employees and external regulatory bodies on the overall compliance strategy, which may include interacting with various departments to advise, promote, and develop professional validation services internally.
• Stay updated on regulatory compliance organizations' developments to advise both internal and external customers on changing trends and requirements.
• Provide support to the internal QA team if needed, including reviewing and revising system validation-related Standard Operating Procedures and Work Instructions.
• Deliver training and mentoring in computer systems validation to relevant personnel.
• Initiate and enforce necessary system corrections and improvements via system change controls and mitigation plans.
• Report to management on issues such as non-conforming product and conflicting priorities.

Desired Competencies :

• Demonstrates a proactive attitude and represents the organization professionally.
• Works well under supervision and seeks support for continuous learning.
• Self-motivated with strong organizational and time management skills.
• Capable of identifying and leading customer inquiries to the sales team.
• Committed to continuous development of product knowledge.
• Excellent communicator with a strong customer focus and relationship-building skills.

Job Qualifications :

• Proven experience as a CSV specialist in a consulting organization.
• In-depth knowledge of validation deliverables at each stage of the computer system lifecycle.
• Familiarity with industry standards and regulatory guidelines such as 21 CFR Part 11, Annex 11, Annex 15, GxP, ISO / IEC / IEEE.
• Experience with generating and reviewing validation deliverables for various types of software.
• Familiarity with change control processes, CAPA, and Quality Systems.
• strong organization, time management, critical thinking, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work in cross-functional teams and build consensus.
• Some project management skills required.
• Proficiency in Microsoft Office Suite, particularly Excel, Word, and Project.

qualifications :

• Experience level :
• Minimum 5 years of experience
• Education : Bachelors
skills :
• Validation
• Validation
• Compliance
30+ days ago