Bridgepoint places ERP Quality, Validation, CSV/CSA, and quality systems professionals on a contract or direct hire basis. Both models are scoped around your GxP manufacturing environment, validated production systems, and regulatory context.
Staff augmentation fits when you need qualified validation capacity for a defined period: an ERP upgrade, a CSV remediation program, pre-approval inspection readiness, or a regulatory timeline that cannot wait for a permanent hire to come on board. Contract professionals integrate into your team, work within your processes, and support your manufacturing operations under your direction.
We place contract professionals across the full ERP validation lifecycle: IQ/OQ/PQ protocol development and execution, change control documentation, system acceptance, and ongoing GxP production support. Screening accounts for regulatory depth in FDA-regulated operations, platform-specific experience, and the candidate's history of working under inspection pressure.
Typical engagements include SAP S/4HANA validation programs at pharmaceutical manufacturers, Oracle Cloud ERP migrations in GxP environments, MES/LIMS integration validation at biotech and CDMO sites, and CSV remediation initiatives tied to FDA Form 483 observations or pre-approval inspection timelines.
Permanent placement for validation leadership, quality systems ownership, ERP governance, and GxP compliance roles requiring site-level institutional knowledge. Direct hire searches are scoped with the same regulatory rigor as contract work: system environment, audit history, manufacturing context, and the specific compliance demands of the role.
We work with a focused number of clients so each search receives the attention it requires. You receive a concise shortlist matched to your regulatory posture, production system environment, and the specific organizational context of the role.
Pharmaceutical manufacturers, biotech organizations, medical device companies, and CDMOs engage us across a range of validation, remediation, and compliance-critical manufacturing talent needs.
Pharmaceutical manufacturers mid-ERP upgrade or revalidation without sufficient internal headcount to manage IQ/OQ/PQ and change control requirements.
A pharmaceutical manufacturer under FDA warning letter needs a CSV specialist and quality systems professional to support manufacturing remediation commitments within the agency's required timeline.
A biotech company transitioning from clinical to commercial manufacturing needs an ERP validation lead and quality systems professional experienced in biologics GMP production environments.
A growing CDMO adding pharmaceutical manufacturing clients needs a permanent Quality Systems Manager with multi-client GMP experience and validated ERP knowledge to own compliance infrastructure across programs.
A biotech preparing for its first FDA pre-approval inspection needs contract CSV and documentation support to ensure manufacturing ERP systems and electronic records meet Part 11 and Annex 11 requirements before the inspection window.
A medical device manufacturer implementing a new ERP needs contract support from professionals who understand 21 CFR Part 820, ISO 13485, and the validation implications for manufacturing design control and CAPA modules.
Describe the role, your GxP manufacturing environment, and the regulatory context. We'll structure the engagement around what your organization actually needs.