CSV & DI Compliance Manager

Scientific Protein Laboratories•Waunakee, WI

3d•Onsite

About The Position

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a CSV & DI Compliance Manager. In this role you will establish, govern, and sustain the computerized system validation (CSV) and data integrity (DI) program for all GxP computerized systems at the SPL Waunakee site, across IT business and laboratory systems and OT process systems. You will set the site’s CSV and DI standards, procedures, and policies across Quality, IT, and Engineering, and direct the IT and OT teams that implement them ensuring that every GxP system is validated, compliant, and defensible under regulatory inspection. This role will manage the CSV Engineer, provide functional direction to the automation engineers performing hands-on OT work, and partner with QA Validation, which retains independent review and final approval. Serve as the site’s primary computerized systems subject matter expert during FDA, customer, and internal inspections and audits. Perform duties at an elevated degree of professionalism, independence, and sense of ownership.

Requirements

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

Nice To Haves

3+ years leading a CSV or data integrity program or team, including authoring site standards and procedures.
3+ years validating OT and automation systems (PLC, HMI, SCADA, historians).

Responsibilities

Own the site’s CSV and data integrity program: Establish and maintain the standards, procedures, and policies that govern all GxP computerized systems, based on 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, ICH Q7, GAMP 5, and ALCOA+ principles, developed to consensus across IT, Engineering, QA, and Validation and approved through SPL’s quality system.
Direct and oversee the CSV and data integrity work performed by the IT team on business and laboratory systems and by the OT team on process systems, including PLCs, HMIs, SCADA, and historians, setting expectations, reviewing deliverables, and driving both teams to build and maintain defensible systems.
Manage and develop the CSV Engineer and provide functional direction on CSV and data integrity matters to the automation engineers who perform hands-on OT validation and data integrity work.
Build and maintain the site’s risk-based CSV and data integrity program plan: Prioritize systems and gaps by patient safety, product quality, and data integrity risk, sequence the work in phases, and reprioritize as new gaps are identified.
Lead and track CSV and data integrity compliance gap remediation, including CAPA actions and findings from data integrity assessments, and coordinate completion across departments.
Govern the CSV lifecycle for all GxP computerized systems, from requirements through periodic review and retirement, in coordination with the System Owners and Process Owners in IT, Engineering, Quality, and Operations.
Govern the data integrity program across all GxP computerized systems, including account and role-based access governance, 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 the governing SOP’s classification principles as the reference.
Develop validation-ready documentation standards and templates that QA Validation can execute and approve against, and review validation strategies and deliverables with recommendations; validation execution and final approval remain with QA Validation.
Ensure CSV and data integrity impact assessment within change control for every change affecting a GxP computerized system, including determining when revalidation is required.
Establish and lead the periodic review program for validated systems, defining review cadence by risk and tracking outcomes to closure.
Serve as the site’s primary subject matter expert for computerized systems during FDA, customer, and internal inspections and audits: Present and defend the site’s systems and controls, ensure CSV and data integrity evidence is current, traceable, and retrievable, and lead responses and corrective action planning.
Manage external CSV consultants and contractors, including scope definition, prioritization of work, and oversight of deliverables.
Partner with QA Validation leadership so that CSV and data integrity work is documented to standard and aligned with SPL’s quality systems and policies and escalate unresolved cross-functional issues to the Director of Engineering & Maintenance, with Quality as the final authority on compliance questions.
Provide regular CSV and data integrity compliance status reporting to the Director of Engineering & Maintenance and site leadership, including remediation progress, CAPA status, and program metrics.
Serve as the site’s 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 to build data integrity awareness across the site.
Work with Quality Systems group to align CSV and data integrity procedures with the Document Control and Change Control Programs.
Assess CSV and data integrity resource needs as the program matures and recommend staffing and support configurations to sustain the validated state.
Implement metrics necessary to monitor the effectiveness and continual improvement of the CSV and data integrity program.
Support off work hour emergency situations related to incidents affecting GxP computerized systems or data integrity.