The Role
Leads computer system validation and compliance for computerized manufacturing and laboratory systems in a GMP pharmaceutical environment. Oversees validation lifecycle documentation, risk assessments, qualification, change controls, deviations, CAPA, data integrity, audits, and regulatory inspections. Advises cross-functional Quality, Engineering, Automation, IT, Manufacturing, and Laboratory teams while tracking project deliverables and compliance milestones. Requires experience with platforms such as DeltaV, Rockwell or Siemens PLCs, process historians, or laboratory automation systems, with onsite work twice weekly in West Point, Pennsylvania.
Summary Generated by Built In
We are seeking an experienced Computer System Validation (CSV) Lead to provide validation and compliance oversight for computerized manufacturing and laboratory systems within a GMP-regulated pharmaceutical environment.
The successful candidate will support capital and strategic projects, lead validation lifecycle activities, and advise cross-functional teams on GxP, Computer Software Assurance, qualification, risk management, and change control requirements.
- Lead CSV and compliance activities for computerized manufacturing and laboratory systems.
- Provide validation oversight for capital and strategic projects.
- Develop, review, and approve validation lifecycle documentation in accordance with GxP requirements, internal SOPs, and regulatory expectations.
- Guide project teams on CSV, CSA, SDLC, qualification, risk-based validation, and change control processes.
- Support the preparation and execution of IQ, OQ, and PQ documentation.
- Facilitate system risk assessments and ensure identified risks are appropriately documented and mitigated.
- Coordinate deviation management, CAPA activities, change controls, and compliance-related issue resolution.
- Ensure computerized systems meet data integrity and lifecycle compliance requirements.
- Collaborate with Quality, Validation, Engineering, Automation, IT, Laboratory, and Manufacturing stakeholders.
- Track validation deliverables, compliance milestones, risks, dependencies, and project status.
- Support regulatory inspections and internal or external audits when required.
Requirements
- Strong hands-on experience in Computer System Validation within a GMP-regulated pharmaceutical or manufacturing environment.
- Experience validating computerized manufacturing, automation, or laboratory systems.
- Strong knowledge of:
- GxP and data integrity requirements
- Computer System Validation and Computer Software Assurance
- Validation lifecycle management
- Software Development Life Cycle
- IQ, OQ, and PQ qualification
- Risk-based validation
- Change control
- Deviations and CAPA
- System lifecycle and compliance management
- GxP and data integrity requirements
- Experience developing, reviewing, and approving validation protocols, reports, risk assessments, traceability documentation, and other compliance deliverables.
- Familiarity with FDA requirements, including 21 CFR Part 11, and relevant pharmaceutical industry regulations and guidance.
- Strong stakeholder-management, documentation, communication, and project-coordination skills.
- Ability to work onsite in West Point, Pennsylvania, twice per week.
Experience with at least one of the following manufacturing or laboratory platforms is required:
- DeltaV DCS
- Rockwell and/or Siemens PLC systems
- Process historians
- Laboratory automation systems
- Previous experience supporting pharmaceutical manufacturing or laboratory capital projects.
- Ability to provide independent compliance guidance to technical and business stakeholders.
- Experience working across Quality, IT, Engineering, Automation, Manufacturing, and Laboratory functions.
- Availability to join at short notice.
Benefits
- Location: USA – West Point, Pennsylvania
- Contract Type: Freelance / Contract
- Start date: September, 2026
- Time Allocation: 40 hours/week
- Pharmaceutical industry
Skills Required
- Hands-on Computer System Validation experience in a GMP-regulated pharmaceutical or manufacturing environment
- Experience validating computerized manufacturing, automation, or laboratory systems
- Knowledge of GxP and data integrity requirements
- Knowledge of Computer System Validation and Computer Software Assurance
- Knowledge of validation lifecycle management and Software Development Life Cycle
- Knowledge of IQ, OQ, and PQ qualification
- Knowledge of risk-based validation and change control
- Knowledge of deviations, CAPA, and system lifecycle compliance management
- Experience developing, reviewing, and approving validation protocols, reports, risk assessments, traceability documentation, and compliance deliverables
- Familiarity with FDA requirements, including 21 CFR Part 11, and pharmaceutical regulations and guidance
- Stakeholder-management, documentation, communication, and project-coordination skills
- Experience with DeltaV DCS, Rockwell or Siemens PLC systems, process historians, or laboratory automation systems
- Ability to work onsite in West Point, Pennsylvania, twice per week
- Experience supporting pharmaceutical manufacturing or laboratory capital projects
- Ability to provide independent compliance guidance to technical and business stakeholders
- Experience working across Quality, IT, Engineering, Automation, Manufacturing, and Laboratory functions
- Availability to join at short notice
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The Company
What We Do
futureproof s.r.o. is a Czech consulting and staffing firm focused on data, analytics, cybersecurity, and IT infrastructure. It provides contract and permanent staffing, team augmentation, time-and-material resources, and specialist or lead placements, while also offering expert consulting through a network of architects and project leaders. The company emphasizes niche technical expertise, trusted relationships, continuous learning, and long-term value for clients.
