CSV & DI Compliance Manager

Scientific Protein Laboratories•Waunakee, WI

34d•Onsite

About The Position

Scientific Protein Laboratories (SPL), a biopharmaceutical company specializing in the development and cGMP-compliant manufacturing of active pharmaceutical ingredients, is hiring a CSV & DI Compliance Manager for its Waunakee, Wisconsin site. The role establishes, governs, and sustains the site’s computerized system validation (CSV) and data integrity (DI) program for GxP computerized systems across IT business and laboratory systems and OT process systems. The manager sets site standards, procedures, and policies across Quality, IT, and Engineering, and directs implementation so systems remain validated, compliant, and defensible during regulatory inspections. The position manages the CSV Engineer, provides functional direction to automation engineers performing OT work, and partners with QA Validation, which retains independent review and final approval. The manager serves as the site’s primary computerized systems subject matter expert during FDA, customer, and internal inspections and audits, and performs duties with a high degree of professionalism, independence, and ownership. The role reports compliance status to the Director of Engineering & Maintenance and site leadership, and escalates unresolved cross-functional issues to that director. Quality remains the final authority on compliance questions. The position also supports off-hours emergency situations involving incidents that affect GxP computerized systems or data integrity.

Requirements

Bachelor’s degree in engineering, computer science, life sciences, or a related technical field.
At least 8 years of CSV and data integrity experience for GMP computerized systems in a pharmaceutical, biotech, or API manufacturing environment, across the full lifecycle and including IT and laboratory systems.
At least 3 years of direct support for FDA or equivalent regulatory inspections, including presenting and defending computerized systems and leading inspection responses and CAPA remediation.

Nice To Haves

At least 3 years leading a CSV or data integrity program or team, including authoring site standards and procedures.
At least 3 years validating OT and automation systems, including PLCs, HMIs, SCADA, and historians.

Responsibilities

Establish and maintain site CSV and data integrity standards, procedures, and policies based on applicable regulations, guidance, and principles, and secure approval through the quality system.
Direct and oversee CSV and data integrity work by IT for business and laboratory systems and by OT for process systems, including PLCs, HMIs, SCADA, and historians.
Manage and develop the CSV Engineer and provide functional direction to automation engineers on CSV and data integrity matters.
Build and maintain a risk-based CSV and data integrity program plan, prioritizing systems and gaps by patient safety, product quality, and data integrity risk.
Lead and track compliance gap remediation, including CAPA actions and findings from data integrity assessments, coordinating completion across departments.
Govern the CSV lifecycle for GxP computerized systems from requirements through periodic review and retirement, in coordination with system and process owners.
Govern data integrity practices, including account and role-based access, audit trail review expectations, time synchronization, backup and restore evidence, and exception handling.
Maintain the site’s GxP computerized system inventory and configuration baselines, and make GxP impact and GAMP 5 classification determinations using governing SOP principles.
Develop validation-ready documentation standards and templates, and review validation strategies and deliverables with recommendations; QA Validation executes and provides final approval.
Ensure CSV and data integrity impact assessments are performed within change control for changes affecting GxP computerized systems, including determining when revalidation is required.
Establish and lead risk-based periodic reviews for validated systems, defining review cadence and tracking outcomes to closure.
Serve as the site’s primary computerized systems subject matter expert during FDA, customer, and internal inspections and audits; present and defend systems and controls, ensure evidence is current and retrievable, and lead responses and corrective action planning.
Manage external CSV consultants and contractors, including defining scope, prioritizing work, and overseeing deliverables.
Partner with QA Validation leadership to ensure work is documented to standard and aligned with SPL quality systems and policies; escalate unresolved cross-functional issues to the Director of Engineering & Maintenance.
Provide regular compliance status reporting to the Director of Engineering & Maintenance and site leadership, including remediation progress, CAPA status, and program metrics.
Serve as the site liaison with HQ CSV for framework alignment and best-practice guidance.
Develop and deliver CSV and data integrity training for system users, administrators, and engineers.
Work with the Quality Systems group to align CSV and data integrity procedures with Document Control and Change Control programs.
Assess program resource needs as the program matures and recommend staffing and support configurations to sustain the validated state.
Implement metrics to monitor program effectiveness and continual improvement.
Support off-work-hour emergency situations involving incidents affecting GxP computerized systems or data integrity.