CSV/Compliance Lead

Valspec•Royersford, PA

About The Position

Valspec is seeking a CSV / Compliance Lead with a proven track record in the SDLC (System Development Life Cycle) for regulated computer systems within biopharmaceutical environments. This individual will serve as a technical leader responsible for ensuring systems are validated, compliant, and audit-ready across the full lifecycle. This role supports the execution of CSV and compliance-focused projects and programs. The CSV / Compliance Lead will be responsible for developing and overseeing validation strategies, quality plans, and compliance frameworks while ensuring consistency, traceability, and regulatory alignment.

Requirements

8–12+ years of Computer System Validation (CSV) / Compliance experience within life sciences
Experience supporting automation systems, MES, enterprise systems (SAP, PAS-X), and/or infrastructure validation
Strong knowledge of SDLC, data integrity, and regulatory compliance frameworks
Direct experience developing and executing validation protocols and lifecycle documentation
Experience leading validation strategy, compliance programs, and risk-based approaches
Knowledge of industry standards such as GAMP 5, CSA (Computer Software Assurance), and ASTM E2500
Experience with change control, deviation management, and CAPA processes
Strong client-facing communication skills with the ability to influence quality and compliance decisions
Passion for leading, mentoring, and developing junior resources
Candidates must be legally eligible to work in the United States without company sponsorship.
Not interested in working on a corp-to-corp basis with other companies at this time.

Nice To Haves

Experience with systems such as DeltaV, Rockwell Automation (Allen Bradley), Siemens, OSI PI, MES platforms (PAS-X), and enterprise systems (SAP)
Experience with validation lifecycle management tools (e.g., Kneat, ValGenesis)
Prior experience acting as a CSV Lead, Compliance Lead, or Program Lead on large-scale capital projects

Responsibilities

Driving CSV and compliance deliverables to completion across multiple systems and workstreams
Leading the development of Validation Master Plans, Compliance Plans, and Quality Assurance strategies
Overseeing the execution of validation deliverables including protocols (IQ/OQ/PQ), reports, traceability matrices, and risk assessments
Ensuring all systems are designed, tested, and documented in accordance with regulatory expectations and project requirements
Reviewing vendor documentation (URS, design specifications, FAT/SAT protocols) and ensuring compliance alignment
Supporting data integrity initiatives, change control processes, and deviation/CAPA management
Participating in regulatory inspections, internal audits, and client quality reviews
Providing leadership, mentorship, and guidance to validation and compliance engineers