CSV Engineer (Louisville, CO/Remote)

This is a remote position.

CSV Consultant – LIMS Upgrade

About the Opportunity

Pioneer GMP Consulting is seeking an experienced CSV Consultant to join our team for a client engagement supporting the upgrade of a Laboratory Information Management System within a GMP-regulated environment.

This initial engagement will require hands-on validation planning, documentation development, testing, discrepancy resolution, and implementation support throughout the system-upgrade lifecycle. The work is expected to be performed primarily remotely, with approximately one to two visits to the client site in Louisville, Colorado, currently anticipated.

This is not a remote oversight or strategy-only position. You will work directly with Laboratory, Quality, IT, system-administration, business-process, vendor, and implementation stakeholders to independently move validation deliverables forward.

The final scope, schedule, duration, level of effort, onsite requirements, and required deliverables remain subject to client approval and detailed project planning. Additional system information will be shared with qualified candidates at the appropriate stage of the recruiting process.

You will join Pioneer as a consultant—not as an employee assigned permanently to one project. If this initial engagement concludes, we will work to identify another opportunity aligned with your experience and capabilities. Future assignments may involve different clients, systems, responsibilities, schedules, locations, work arrangements, or travel requirements. Their timing and availability depend on client demand and cannot be guaranteed.

What You’ll Do

• Support the validation of a GMP-regulated LIMS upgrade
  
• Review the existing system’s intended use, configuration, validation status, and lifecycle documentation
  
• Assess the proposed upgrade and help establish an appropriate risk-based validation strategy
  
• Develop or update the validation plan and supporting computer-system lifecycle documentation
  
• Facilitate and document system-impact and GxP risk assessments
  
• Support change-control activities associated with the upgrade
  
• Develop, review, or revise user requirements, functional requirements, configuration specifications, and traceability documentation
  
• Develop, review, and execute validation test scripts
  
• Support installation, operational, performance, regression, and user-acceptance testing as applicable
  
• Verify configured workflows, calculations, specifications, reports, security roles, audit trails, electronic records, and electronic signatures as applicable
  
• Support validation of interfaces, integrations, reports, and data-migration activities included in the final scope
  
• Document, investigate, and resolve test discrepancies, defects, deviations, and validation gaps
  
• Maintain requirements traceability and objective evidence throughout execution
  
• Prepare validation-summary reports and support final system-release documentation
  
• Collaborate with Laboratory, Quality, IT, system administrators, business-process owners, vendors, and implementation partners
  
• Manage assigned deliverables independently and communicate progress, risks, constraints, and readiness concerns
  
• Ensure validation documentation is complete, accurate, traceable, defensible, and inspection-ready
  
• Represent Pioneer with professionalism, technical credibility, sound judgment, responsiveness, and accountability
  

What Success Looks Like

You will be successful in this role when:

• A clear, risk-based validation approach is established and followed
  
• Requirements, risks, specifications, testing, discrepancies, and final conclusions remain traceable
  
• Test scripts are accurate, executable, and appropriately focused on GxP and business-process risks
  
• Validation gaps, defects, discrepancies, and deviations are identified and resolved appropriately
  
• Documentation is complete, defensible, and inspection-ready
  
• Risks, constraints, documentation needs, and potential delays are communicated early
  
• You establish credibility quickly and remain productive without extensive day-to-day direction
  
• Client stakeholders view you as knowledgeable, responsive, dependable, and solutions-oriented
  
• You balance client service with sound technical, quality, and compliance judgment
  
• You remain accountable and responsive to both the client and Pioneer
  

Required Qualifications

• At least five years of computer system validation experience in GMP pharmaceutical, biotechnology, laboratory, or life sciences environments
  
• Direct experience validating LIMS implementations, upgrades, or significant system changes
  
• Experience developing and executing risk-based computer system validation documentation
  
• Experience with validation plans, requirements, risk assessments, specifications, test scripts, traceability matrices, discrepancy management, and validation-summary reports
  
• Experience supporting system, regression, and user-acceptance testing
  
• Experience evaluating configurable workflows, reports, calculations, security roles, audit trails, electronic records, or system interfaces
  
• Understanding of laboratory workflows and the regulated use of laboratory data
  
• Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, data-integrity principles, and applicable system-lifecycle requirements
  
• Strong technical-writing, organization, documentation-review, and problem-solving skills
  
• Ability to independently manage detailed validation deliverables in an embedded, client-facing environment
  
• Ability to establish credibility, build working relationships, and influence outcomes without direct authority
  
• Ability to remain responsive and available during agreed-upon client working hours
  
• Ability to travel to Louisville, Colorado, for limited onsite project activities
  
• Ability to adapt as project scope, priorities, schedules, deliverables, and onsite needs evolve
  
• Bachelor’s degree in information systems, computer science, engineering, life sciences, or a related field, or equivalent relevant industry experience
  

What Will Set You Apart

• Prior life sciences consulting or staff-augmentation experience, with demonstrated success entering new client environments, establishing credibility quickly, managing deliverables independently, adapting to changing priorities, and balancing accountability to both the consulting firm and the client
  
• Experience validating a major LIMS version upgrade
  
• Experience with LIMS configuration, workflows, specifications, sample lifecycle management, calculations, and results reporting
  
• Experience validating LIMS interfaces with laboratory instruments, CDS, ERP, MES, or other GxP systems
  
• Experience supporting validated data migration
  
• Experience validating security roles, audit trails, electronic records, electronic signatures, reports, and system interfaces
  
• Experience applying Computer Software Assurance and risk-based testing principles
  
• Experience working directly with LIMS vendors, system integrators, laboratory users, and Quality stakeholders
  
• Experience supporting system release, implementation readiness, and post-upgrade stabilization
  
• Experience entering an active project and becoming productive with minimal ramp-up time
  
• Flexibility to support additional onsite activities if project needs change
  

Candidates without a formal consulting title may demonstrate comparable readiness through contract assignments, staff-augmentation work, remediation projects, cross-site responsibilities, external manufacturing oversight, or other roles requiring rapid integration into unfamiliar environments.

What Consulting at Pioneer Requires

Working at Pioneer is different from working in a traditional, fixed position. You will be a Pioneer employee while operating as an embedded member of a client team.

Client-Centric Judgment

You will take time to understand the client’s needs, build trusted relationships, and deliver practical results. Being client-centric does not mean simply agreeing with the client. It means communicating respectfully, offering sound recommendations, protecting quality and compliance, and helping the client move forward.

Flexibility and Adaptability

Client priorities, schedules, responsibilities, timelines, and project requirements may change. You must be comfortable adjusting your approach, learning new systems and processes, and contributing beyond a narrowly defined task list when your capabilities can add value.

Hands-On Delivery

This is an individual-contributor consulting role. Regardless of experience or seniority, you will be expected to develop and review documents, execute testing, investigate issues, resolve discrepancies, manage deliverables, and complete detailed project work.

Ownership and Responsiveness

Clients rely on consultants to honor commitments, meet deadlines, participate in required meetings, remain accessible during agreed-upon working hours, and raise risks or constraints early.

One Employee, Two Teams

You will work closely with the client while continuing to represent Pioneer. You are expected to follow client procedures, protect confidential information, maintain appropriate professional boundaries, and remain connected and accountable to Pioneer throughout the engagement.

Future Assignments

The primarily remote arrangement and limited travel expectations described above apply to this initial engagement. Future Pioneer assignments may require different expertise or responsibilities and may be remote, hybrid, or fully onsite. They may also involve additional travel, overnight stays, or extended onsite support.

We will consider alignment with your experience and capabilities when identifying future opportunities; however, assignment availability, timing, location, and requirements depend on client demand.

How Pioneer Supports You

Although you will work closely with the client, you will remain connected to Pioneer.

As a Pioneer employee, you can expect:

• Access to Pioneer leadership
  
• Connection to an internal network of experienced life sciences professionals
  
• Support navigating client relationships, priorities, and challenges
  
• Regular communication regarding your engagement and performance
  
• Clear expectations regarding your client assignment and responsibilities
  
• Opportunities to contribute your expertise to Pioneer’s broader team
  
• Consideration for future client opportunities aligned with your capabilities
  
• A culture that values expertise, humility, responsiveness, accountability, and strong relationships
  

About Pioneer GMP Consulting

Pioneer GMP Consulting was founded by consultants with real-world operating experience who understand the realities of the life sciences industry: demanding timelines, complex regulatory environments, changing priorities, and high expectations.

We provide quality, compliance, validation, engineering, regulatory, technology, and operational support to pharmaceutical, biotechnology, and life sciences organizations.

We apply critical thinking, Lean GMP principles, and practical solutions to evolve traditional GMP practices. To us, GMP is not only about compliance. It is also about building systems that are effective, efficient, scalable, and appropriate for the organization.

Benefits

Eligible regular, full-time employees may receive:

• Medical insurance, with Pioneer currently contributing 50% of employee premiums
  
• Dental insurance
  
• Vision insurance
  
• $100,000 basic life insurance
  
• 401(k) retirement plan
  
• 12 paid holidays
  
• Flexible PTO
  
• Direct access to Pioneer leadership
  
• Opportunities to support high-impact client engagements
  

Benefit eligibility will depend on final employment classification and schedule. Benefits are subject to eligibility requirements and the applicable plan documents. Benefit offerings may change over time.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.